Pro-Hdl may be available in the countries listed below.
Ingredient matches for Pro-Hdl
Lovastatin
Lovastatin is reported as an ingredient of Pro-Hdl in the following countries:
- India
International Drug Name Search
Thursday, September 29, 2016
Ziagen
abacavir sulfate
Dosage Form: tablet,film coated; oral solution
FULL PRESCRIBING INFORMATION
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with Ziagen® (abacavir sulfate).
Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue Ziagen as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue Ziagen if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart Ziagen or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of Ziagen or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours [see Warnings and Precautions (5.1)].
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Ziagen and other antiretrovirals [see Warnings and Precautions (5.2)].
Indications and Usage for Ziagen
Ziagen Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Additional important information on the use of Ziagen for treatment of HIV-1 infection:
Ziagen is one of multiple products containing abacavir. Before starting Ziagen, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir [see Warnings and Precautions (5.1), Adverse Reactions (6)].
Ziagen Dosage and Administration
- A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
- To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425.
- Ziagen may be taken with or without food.
Adult Patients
The recommended oral dose of Ziagen for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.
Pediatric Patients
The recommended oral dose of Ziagen Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents.
Ziagen is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing Ziagen Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow Ziagen Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of Ziagen Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Weight (kg) | Dosage Regimen Using Scored Tablet | Total Daily Dose | |
| AM Dose | PM Dose | ||
| 14 to 21 | ½ tablet (150 mg) | ½ tablet (150 mg) | 300 mg |
| >21 to <30 | ½ tablet (150 mg) | 1 tablet (300 mg) | 450 mg |
| ≥30 | 1 tablet (300 mg) | 1 tablet (300 mg) | 600 mg |
Patients with Hepatic Impairment
The recommended dose of Ziagen in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, Ziagen Oral Solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, Ziagen is contraindicated in these patients.
Dosage Forms and Strengths
Ziagen Tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides.
Ziagen Oral Solution contains 20 mg/mL of abacavir as abacavir sulfate. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid.
Contraindications
Ziagen is contraindicated in patients with:
- previously demonstrated hypersensitivity to abacavir or any other component of the products. NEVER restart Ziagen or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status [see Warnings and Precautions (5.1), Adverse Reactions (6)].
- moderate or severe hepatic impairment [see Dosage and Administration (2.3)].
Warnings and Precautions
Hypersensitivity Reaction
Serious and sometimes fatal hypersensitivity reactions have been associated with Ziagen and other abacavir-containing products. Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of a hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended and should be considered only with close medical supervision and under exceptional circumstances when the potential benefit outweighs the risk.
HLA-B*5701-negative patients may develop a hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients. Regardless of HLA-B*5701 status, permanently discontinue Ziagen if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Important information on signs and symptoms of hypersensitivity, as well as clinical management, is presented below.
Signs and Symptoms of Hypersensitivity: Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups.
Group 1: Fever
Group 2: Rash
Group 3: Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
Group 4: Constitutional (including generalized malaise, fatigue, or achiness)
Group 5: Respiratory (including dyspnea, cough, or pharyngitis).
Hypersensitivity to abacavir following the presentation of a single sign or symptom has been reported infrequently.
Hypersensitivity to abacavir was reported in approximately 8% of 2,670 patients (n = 206) in 9 clinical trials (range: 2% to 9%) with enrollment from November 1999 to February 2002. Data on time to onset and symptoms of suspected hypersensitivity were collected on a detailed data collection module. The frequencies of symptoms are shown in Figure 1. Symptoms usually appeared within the first 6 weeks of treatment with abacavir, although the reaction may occur at any time during therapy. Median time to onset was 9 days; 89% appeared within the first 6 weeks; 95% of patients reported symptoms from 2 or more of the 5 groups listed above.
Figure 1. Hypersensitivity-Related Symptoms Reported With ≥10% Frequency in Clinical Trials (n = 206 Patients)
Other less common signs and symptoms of hypersensitivity include lethargy, myolysis, edema, abnormal chest x-ray findings (predominantly infiltrates, which can be localized), and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, and death have occurred in association with hypersensitivity reactions. In one study, 4 patients (11%) receiving Ziagen 600 mg once daily experienced hypotension with a hypersensitivity reaction compared with 0 patients receiving Ziagen 300 mg twice daily.
Physical findings associated with hypersensitivity to abacavir in some patients include lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and rash. The rash usually appears maculopapular or urticarial, but may be variable in appearance. There have been reports of erythema multiforme. Hypersensitivity reactions have occurred without rash.
Laboratory abnormalities associated with hypersensitivity to abacavir in some patients include elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia.
Clinical Management of Hypersensitivity: Discontinue Ziagen as soon as a hypersensitivity reaction is suspected. To minimize the risk of a life-threatening hypersensitivity reaction, permanently discontinue Ziagen if hypersensitivity cannot be ruled out, even when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications).
Following a hypersensitivity reaction to abacavir, NEVER restart Ziagen or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
When therapy with Ziagen has been discontinued for reasons other than symptoms of a hypersensitivity reaction, and if reinitiation of Ziagen or any other abacavir-containing product is under consideration, carefully evaluate the reason for discontinuation of Ziagen to ensure that the patient did not have symptoms of a hypersensitivity reaction. If the patient is of unknown HLA-B*5701 status, screening for the allele is recommended prior to reinitiation of Ziagen.
If hypersensitivity cannot be ruled out, DO NOT reintroduce Ziagen or any other abacavir-containing product. Even in the absence of the HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction.
If symptoms consistent with hypersensitivity are not identified, reintroduction can be undertaken with continued monitoring for symptoms of a hypersensitivity reaction. Make patients aware that a hypersensitivity reaction can occur with reintroduction of Ziagen or any other abacavir-containing product and that reintroduction of Ziagen or any other abacavir-containing product needs to be undertaken only if medical care can be readily accessed by the patient or others.
Risk Factor: HLA-B*5701 Allele: Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir.
CNA106030 (PREDICT-1), a randomized, double-blind study, evaluated the clinical utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity reaction in abacavir-naive HIV-1-infected adults (n = 1,650). In this study, use of pre-therapy screening for the HLA-B*5701 allele and exclusion of subjects with this allele reduced the incidence of clinically suspected abacavir hypersensitivity reactions from 7.8% (66/847) to 3.4% (27/803). Based on this study, it is estimated that 61% of patients with the HLA-B*5701 allele will develop a clinically suspected hypersensitivity reaction during the course of abacavir treatment compared with 4% of patients who do not have the HLA-B*5701 allele.
Screening for carriage of the HLA -B*5701 allele is recommended prior to initiating treatment with abacavir. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. For HLA-B*5701-positive patients, initiating or reinitiating treatment with an abacavir-containing regimen is not recommended and should be considered only with close medical supervision and under exceptional circumstances where potential benefit outweighs the risk.
Skin patch testing is used as a research tool and should not be used to aid in the clinical diagnosis of abacavir hypersensitivity.
In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision-making. Even in the absence of the HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction.
Abacavir Hypersensitivity Reaction Registry: An Abacavir Hypersensitivity Registry has been established to facilitate reporting of hypersensitivity reactions and collection of information on each case. Physicians should register patients by calling 1-800-270-0425.
Lactic Acidosis/Severe Hepatomegaly With Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering Ziagen to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Ziagen should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Ziagen. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.
Fat Redistribution
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
Myocardial Infarction
In a published prospective, observational, epidemiological study designed to investigate the rate of myocardial infarction in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of myocardial infarction (MI).1 In a sponsor-conducted pooled analysis of clinical trials, no excess risk of myocardial infarction was observed in abacavir-treated subjects as compared with control subjects. In totality, the available data from the observational cohort and from clinical trials are inconclusive.
As a precaution, the underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors (e.g., hypertension, hyperlipidemia, diabetes mellitus, and smoking).
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious and sometimes fatal hypersensitivity reaction. In one study, once-daily dosing of abacavir was associated with more severe hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.1)].
- Lactic acidosis and severe hepatomegaly [see Boxed Warning, Warnings and Precautions (5.2)].
- Immune reconstitution syndrome [see Warnings and Precautions (5.3].
- Fat redistribution [see Warnings and Precautions (5.4].
- Myocardial infarction [see Warnings and Precautions (5.5)].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults:Therapy-Naive Adults: Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with Ziagen 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 2.
a This study used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the study, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 patients in the abacavir group and 3% of 325 patients in the zidovudine group. | ||
b Ten (3%) cases of suspected drug hypersensitivity were reclassified as not being due to abacavir following unblinding. | ||
Adverse Reaction | Ziagen plus Lamivudine plus Efavirenz (n = 324) | Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Dreams/sleep disorders | 10% | 10% |
Drug hypersensitivity | 9% | <1%b |
Headaches/migraine | 7% | 11% |
Nausea | 7% | 11% |
Fatigue/malaise | 7% | 10% |
Diarrhea | 7% | 6% |
Rashes | 6% | 12% |
Abdominal pain/gastritis/ | 6% | 8% |
Depressive disorders | 6% | 6% |
Dizziness | 6% | 6% |
Musculoskeletal pain | 6% | 5% |
Bronchitis | 4% | 5% |
Vomiting | 2% | 9% |
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with Ziagen 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 3.
Adverse Reaction | Ziagen plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 264) |
Nausea | 19% | 17% |
Headache | 13% | 9% |
Malaise and fatigue | 12% | 12% |
Nausea and vomiting | 10% | 10% |
Hypersensitivity reaction | 8% | 2% |
Diarrhea | 7% | 5% |
Fever and/or chills | 6% | 3% |
Depressive disorders | 6% | 4% |
Musculoskeletal pain | 5% | 7% |
Skin rashes | 5% | 4% |
Ear/nose/throat infections | 5% | 4% |
Viral respiratory infections | 5% | 5% |
Anxiety | 5% | 3% |
Renal signs/symptoms | <1% | 5% |
Pain (non-site-specific) | <1% | 5% |
Five patients receiving Ziagen in CNA3005 experienced worsening of pre-existing depression compared with none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.
Ziagen Once Daily Versus Ziagen Twice Daily (CNA30021): Treatment-emergent clinical adverse reactions (rated by the investigator as at least moderate) with a greater than or equal to 5% frequency during therapy with Ziagen 600 mg once daily or Ziagen 300 mg twice daily both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily from CNA30021 were similar. For hypersensitivity reactions, patients receiving Ziagen once daily showed a rate of 9% in comparison with a rate of 7% for patients receiving Ziagen twice daily. However, patients receiving Ziagen 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with patients who received Ziagen 300 mg twice daily. Five percent (5%) of patients receiving Ziagen 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of patients receiving Ziagen 300 mg twice daily. Two percent (2%) of patients receiving Ziagen 600 mg once daily had severe diarrhea while none of the patients receiving Ziagen 300 mg twice daily had this event.
Laboratory Abnormalities: Laboratory abnormalities (Grades 3-4) in therapy-naive adults during therapy with Ziagen 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 4.
ULN = Upper limit of normal. | ||
n = Number of patients assessed. | ||
Grade 3/4 Laboratory Abnormalities | Ziagen plus Lamivudine plus Efavirenz (n = 324) | Zidovudine plus Lamivudine plus Efavirenz |
Elevated CPK (>4 X ULN) | 8% | 8% |
Elevated ALT (>5 X ULN) | 6% | 6% |
Elevated AST (>5 X ULN) | 6% | 5% |
Hypertriglyceridemia (>750 mg/dL) | 6% | 5% |
Hyperamylasemia (>2 X ULN) | 4% | 5% |
Neutropenia (ANC <750/mm3) | 2% | 4% |
Anemia (Hgb ≤6.9 gm/dL) | <1% | 2% |
Thrombocytopenia (Platelets <50,000/mm3) | 1% | <1% |
Leukopenia (WBC ≤1,500/mm3) | <1% | 2% |
Laboratory abnormalities in CNA3005 are listed in Table 5.
ULN = Upper limit of normal. | ||
n = Number of patients assessed. | ||
Grade 3/4 Laboratory Abnormalities | Number of Subjects by Treatment Group | |
Ziagen plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 264) | |
Elevated CPK (>4 x ULN) | 18 (7%) | 18 (7%) |
ALT (>5.0 x ULN) | 16 (6%) | 16 (6%) |
Neutropenia (<750/mm3) | 13 (5%) | 13 (5%) |
Hypertriglyceridemia (>750 mg/dL) | 5 (2%) | 3 (1%) |
Hyperamylasemia (>2.0 x ULN) | 5 (2%) | 1 (<1%) |
Hyperglycemia (>13.9 mmol/L) | 2 (<1%) | 2 (<1%) |
Anemia (Hgb ≤6.9 g/dL) | 0 (0%) | 3 (1%) |
The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021.
Pediatric Patients:Therapy-Experienced Pediatric Patients: Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with Ziagen 8 mg/kg twice daily, lamivudine 4 mg/kg twice daily, and zidovudine 180 mg/m2 twice daily compared with lamivudine 4 mg/kg twice daily and zidovudine 180 mg/m2 twice daily from CNA3006 are listed in Table 6.
Adverse Reaction | Ziagen plus Lamivudine plus Zidovudine (n = 102) | Lamivudine plus Zidovudine (n = 103) |
Fever and/or chills | 9% | 7% |
Nausea and vomiting | 9% | 2% |
Skin rashes | 7% | 1% |
Ear/nose/throat infections | 5% | 1% |
Pneumonia | 4% | 5% |
Headache | 1% | 5% |
Laboratory Abnormalities: In Study CNA3006, laboratory abnormalities (anemia, neutropenia, liver function test abnormalities, and CPK elevations) were observed with similar frequencies as in a study of therapy-naive adults (CNA30024). Mild elevations of blood glucose were more frequent in pediatric patients receiving Ziagen (CNA3006) as compared with adult patients (CNA30024).
Other Adverse Events: In addition to adverse reactions and laboratory abnormalities reported in Tables 2, 3, 4, 5, and 6, other adverse reactions observed in the expanded access program were pancreatitis and increased GGT.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of Ziagen. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Ziagen.
Body as a Whole: Redistribution/accumulation of body fat.
Cardiovascular: Myocardial infarction.
Hepatic: Lactic acidosis and hepatic steatosis.
Skin: Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.
There have also been reports of erythema multiforme with abacavir use.
Drug Interactions
7.1 Ethanol
Abacavir has no effect on the pharmacokinetic properties of ethanol. Ethanol decreases the elimination of abacavir causing an increase in overall exposure [see Clinical Pharmacology (12.3)].
7.2 Methadone
The addition of methadone has no clinically significant effect on the pharmacokinetic properties of abacavir. In a study of 11 HIV-1-infected patients receiving methadone-maintenance therapy with 600 mg of Ziagen twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology (12.3)]. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C. Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) and developmental toxicity (depressed fetal body weight and reduced crown-rump length) were observed in rats at a dose which produced 35 times the human exposure, based on AUC. Embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) and toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at half of the above-mentioned dose in separate fertility studies conducted in rats. In the rabbit, no developmental toxicity and no increases in fetal malformations occurred at doses that produced 8.5 times the human exposure at the recommended dose based on AUC.
There are no adequate and well-controlled studies in pregnant women. Ziagen should be used during pregnancy only if the potential benefits outweigh the risk.
Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to Ziagen, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.
Nursing Mothers
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.
Although it is not known if abacavir is excreted in human milk, abacavir is secreted into the milk of lactating rats. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Ziagen.
Pediatric Use
The safety and effectiveness of Ziagen have been established in pediatric patients 3 months to 13 years of age. Use of Ziagen in these age groups is supported by pharmacokinetic studies and evidence from adequate and well-controlled studies of Ziagen in adults and pediatric patients [see Dosage and Administration (2.2), Clinical Pharmacology (12.3), Clinical Studies (14.2)].
Geriatric Use
Clinical studies of Ziagen did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from 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.
Overdosage
There is no known antidote for Ziagen. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.
Ziagen Description
Ziagen is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4 and a molecular weight of 670.76 daltons. It has the following structural formula:
Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25°C. It has an
Zarontin Solution
Pronunciation: ETH-oh-SUX-i-mide
Generic Name: Ethosuximide
Brand Name: Zarontin
Zarontin Solution is used for:
Controlling absence epilepsy (previously known as petit mal seizures). It may also be used for other conditions as determined by your doctor.
Zarontin Solution is an anticonvulsant. It acts in the brain to reduce the number of absence seizures.
Do NOT use Zarontin Solution if:
- you are allergic to any ingredient in Zarontin Solution or similar medicines
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zarontin Solution:
Some medical conditions may interact with Zarontin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver or kidney disease, lupus, or a blood disorder (eg, porphyria)
- if you have a history of mood or mental problems, including suicidal thoughts or attempts
Some MEDICINES MAY INTERACT with Zarontin Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Zarontin Solution
- Valproic acid because it may affect the amount of Zarontin Solution in your blood
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zarontin Solution 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.
How to use Zarontin Solution:
Use Zarontin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- Zarontin Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zarontin Solution refilled.
- Take Zarontin Solution by mouth with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Taking Zarontin Solution at the same time each day will help you remember to take it. Take Zarontin Solution on a regular schedule to get the most benefit from it.
- Continue to take Zarontin Solution even if you feel well. Do not miss any doses.
- If you miss a dose of Zarontin Solution, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zarontin Solution.
Important safety information:
- Zarontin Solution may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zarontin Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zarontin Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Increasing or decreasing the dose as well as adding or stopping other medicines should be done slowly. Rapidly stopping Zarontin Solution may suddenly make absence seizures worse.
- Zarontin Solution may cause swelling and tenderness of your gums. Brush and floss your teeth on a regular schedule and have regular dental checkups.
- Patients who take Zarontin Solution may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zarontin Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Lab tests, including complete blood cell counts, liver function, and kidney function tests, may be performed while you use Zarontin Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Zarontin Solution should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zarontin Solution while you are pregnant. Zarontin Solution is found in breast milk. If you are or will be breast-feeding while you use Zarontin Solution, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Zarontin Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stomach upset; vomiting; weight loss.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased number of seizures; lupus symptoms (eg, butterfly-shaped rash on the face, joint pain or swelling); new or worsening mood or mental changes (eg, depression); nightmares; red, swollen, blistered, or peeling skin; signs of infection (eg, fever, sore throat); suicidal thoughts or attempts; trouble concentrating; trouble sleeping; unusual bruising, bleeding, or fatigue.
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: Zarontin side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include central nervous system depression (eg, coma with slow, shallow breathing); nausea; vomiting.
Proper storage of Zarontin Solution:
Store Zarontin Solution below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Zarontin Solution out of the reach of children and away from pets.
General information:
- If you have any questions about Zarontin Solution, please talk with your doctor, pharmacist, or other health care provider.
- Zarontin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Zarontin Solution. 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.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Zarontin resources
- Zarontin Side Effects (in more detail)
- Zarontin Dosage
- Zarontin Use in Pregnancy & Breastfeeding
- Drug Images
- Zarontin Drug Interactions
- Zarontin Support Group
- 4 Reviews for Zarontin - Add your own review/rating
Compare Zarontin with other medications
- Seizures
Wednesday, September 28, 2016
Penicillin G
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Penicillin G
Benzylpenicillin
Benzylpenicillin potassium (a derivative of Benzylpenicillin) is reported as an ingredient of Penicillin G in the following countries:
- Turkey
Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Penicillin G in the following countries:
- United States
Benzylpenicillin sodium (a derivative of Benzylpenicillin) is reported as an ingredient of Penicillin G in the following countries:
- Georgia
International Drug Name Search
Zgesic
Generic Name: acetaminophen and phenyltoloxamine (a seet a MIN oh fen and FEN il toe LOX a meen)
Brand Names: Aceta-Gesic, Acuflex, Alpain, Apagesic, BeFlex, BP Poly-650, Dologesic, Flextra-650, Flextra-DS, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Percogesic, Phenagesic, Phenylgesic, Q Flex, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Vistra, Vitoxapap, Zgesic
What is Zgesic (acetaminophen and phenyltoloxamine)?
Acetaminophen is a pain reliever and a fever reducer.
Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.
Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Zgesic (acetaminophen and phenyltoloxamine)?
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver or kidney disease, diabetes, glaucoma, urination problems, an enlarged prostate, heart disease, high blood pressure, a stomach ulcer, or an overactive thyroid.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
What should I discuss with my healthcare provider before taking Zgesic (acetaminophen and phenyltoloxamine)?
You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use acetaminophen and phenyltoloxamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
- liver disease or a history of alcoholism;
kidney disease;
diabetes;
glaucoma;
urination problems;
an enlarged prostate;
heart disease or high blood pressure;
a stomach ulcer; or
an overactive thyroid.
It is not known whether acetaminophen and phenyltoloxamine is harmful to an unborn baby. Do not take this medication without telling your doctor if you are pregnant. Acetaminophen and phenyltoloxamine can pass into breast milk and may harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.
How should I take Zgesic (acetaminophen and phenyltoloxamine)?
Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.
One tablet of this medicine may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.
Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Since cold or allergy medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include feeling very restless, extreme drowsiness, warmth or tingly feeling, or seizure (convulsions).
What should I avoid while taking Zgesic (acetaminophen and phenyltoloxamine)?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid becoming overheated or dehydrated during exercise and in hot weather. Phenyltoloxamine can decrease sweating and you may be more prone to heat stroke.
Zgesic (acetaminophen and phenyltoloxamine) 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. Stop using this medication and call your doctor at once if you have a serious side effect such as:
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, nervousness;
urinating less than usual or not at all;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay colored stools, jaundice (yellowing of the skin or eyes); or
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.
Less serious side effects may include:
dizziness, drowsiness;
blurred vision;
dry mouth, nose, or throat;
mild stomach pain, constipation; or
problems with memory or concentration.
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.
What other drugs will affect Zgesic (acetaminophen and phenyltoloxamine)?
Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.
There may be other drugs that can interact with acetaminophen and phenyltoloxamine. 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 Zgesic resources
- Zgesic Side Effects (in more detail)
- Zgesic Use in Pregnancy & Breastfeeding
- Zgesic Drug Interactions
- Zgesic Support Group
- 0 Reviews for Zgesic - Add your own review/rating
- Acuflex MedFacts Consumer Leaflet (Wolters Kluwer)
- Acuflex Consumer Overview
- Lagesic Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Percogesic Consumer Overview
Compare Zgesic with other medications
- Cold Symptoms
- Headache
- Influenza
- Pain
Where can I get more information?
- Your pharmacist can provide more information about acetaminophen and phenyltoloxamine.
See also: Zgesic side effects (in more detail)
Blastoferon
Blastoferon may be available in the countries listed below.
Ingredient matches for Blastoferon
Interferon beta
Interferon beta is reported as an ingredient of Blastoferon in the following countries:
- Argentina
International Drug Name Search
Tuesday, September 27, 2016
Zarontin
Pronunciation: ETH-oh-SUX-i-mide
Generic Name: Ethosuximide
Brand Name: Zarontin
Zarontin is used for:
Controlling absence epilepsy (previously known as petit mal seizures). It may also be used for other conditions as determined by your doctor.
Zarontin is an anticonvulsant. It acts in the brain to reduce the number of absence seizures.
Do NOT use Zarontin if:
- you are allergic to any ingredient in Zarontin or similar medicines
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zarontin:
Some medical conditions may interact with Zarontin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver or kidney disease, lupus, or a blood disorder (eg, porphyria)
- if you have a history of mood or mental problems, including suicidal thoughts or attempts
Some MEDICINES MAY INTERACT with Zarontin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Zarontin
- Valproic acid because it may affect the amount of Zarontin in your blood
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zarontin 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.
How to use Zarontin:
Use Zarontin as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- Zarontin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zarontin refilled.
- Take Zarontin by mouth with or without food.
- Taking Zarontin at the same time each day will help you remember to take it. Take Zarontin on a regular schedule to get the most benefit from it.
- Continue to take Zarontin even if you feel well. Do not miss any doses.
- If you miss a dose of Zarontin, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zarontin.
Important safety information:
- Zarontin may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zarontin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zarontin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Increasing or decreasing the dose as well as adding or stopping other medicines should be done slowly. Rapidly stopping Zarontin may suddenly make absence seizures worse.
- Zarontin may cause swelling and tenderness of your gums. Brush and floss your teeth on a regular schedule and have regular dental checkups.
- Patients who take Zarontin may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zarontin closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Lab tests, including complete blood cell counts and liver and kidney function tests, may be performed while you use Zarontin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Zarontin should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zarontin while you are pregnant. Zarontin is found in breast milk. If you are or will be breast-feeding while you use Zarontin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Zarontin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stomach upset; vomiting; weight loss.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased number of seizures; lupus symptoms (eg, butterfly-shaped rash on the face, joint pain or swelling); new or worsening mood or mental changes (eg, depression); nightmares; red, swollen, blistered, or peeling skin; signs of infection (eg, fever, sore throat); suicidal thoughts or attempts; trouble concentrating; trouble sleeping; unusual bruising, bleeding, or fatigue.
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: Zarontin side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include central nervous system depression (eg, coma with slow, shallow breathing); nausea; vomiting.
Proper storage of Zarontin:
Store Zarontin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Zarontin out of the reach of children and away from pets.
General information:
- If you have any questions about Zarontin, please talk with your doctor, pharmacist, or other health care provider.
- Zarontin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Zarontin. 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.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Zarontin resources
- Zarontin Side Effects (in more detail)
- Zarontin Use in Pregnancy & Breastfeeding
- Drug Images
- Zarontin Drug Interactions
- Zarontin Support Group
- 4 Reviews for Zarontin - Add your own review/rating
- Zarontin Prescribing Information (FDA)
- Zarontin Advanced Consumer (Micromedex) - Includes Dosage Information
- Zarontin Concise Consumer Information (Cerner Multum)
- Zarontin Monograph (AHFS DI)
- Ethosuximide Prescribing Information (FDA)
- Ethosuximide Professional Patient Advice (Wolters Kluwer)
Compare Zarontin with other medications
- Seizures
Enduron
Generic Name: methyclothiazide (Oral route)
meth-i-kloe-THYE-a-zide
Commonly used brand name(s)
In the U.S.
- Aquatensen
- Enduron
Available Dosage Forms:
- Tablet
Therapeutic Class: Cardiovascular Agent
Pharmacologic Class: Diuretic
Chemical Class: Thiazide
Uses For Enduron
Methyclothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .
Methyclothiazide is used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine .
Methyclothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure .
This medicine is available only with your doctor's prescription .
Before Using Enduron
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 methyclothiazide in the pediatric population. Safety and efficacy have not been established .
Geriatric
No information is available on the relationship of age to the effects of methyclothiazide in geriatric patients. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving methyclothiazide .
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 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.
- Acetyldigoxin
- Arsenic Trioxide
- Bepridil
- Deslanoside
- Digitalis
- Digitoxin
- Digoxin
- Dofetilide
- Ketanserin
- Lithium
- Metildigoxin
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.
- Alacepril
- Apazone
- Aspirin
- Benazepril
- Bromfenac
- Captopril
- Celecoxib
- Cilazapril
- Delapril
- Diclofenac
- Diflunisal
- Enalaprilat
- Enalapril Maleate
- Etodolac
- Fenoprofen
- Flurbiprofen
- Fosinopril
- Ginkgo
- Gossypol
- Ibuprofen
- Ibuprofen Lysine
- Imidapril
- Indomethacin
- Ketoprofen
- Ketorolac
- Licorice
- Lisinopril
- Magnesium Salicylate
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Moexipril
- Nabumetone
- Naproxen
- Nepafenac
- Oxaprozin
- Pentopril
- Perindopril
- Piroxicam
- Quinapril
- Ramipril
- Salicylic Acid
- Salsalate
- Spirapril
- Sulindac
- Temocapril
- Tolmetin
- Trandolapril
- Zofenopril
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:
- Anuria (not able to form urine)—Should not be used in patients with this condition .
- Asthma or
- Diabetes or
- Gout or
- Hypercalcemia (high calcium in the blood) or
- Hypercholesterolemia (high cholesterol in the blood) or
- Hyperuricemia (high uric acid in the blood) or
- Hypochloremia (low chloride in the blood) or
- Hypokalemia (low potassium in the blood) or
- Hyponatremia (low sodium in the blood) or
- Hypophosphatemia (low phosphorus in the blood) or
- Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse .
- Kidney disease or
- Liver disease—Use with caution. The effects of the medicine may be increased because of slower removal of the medicine from the body .
Proper Use of methyclothiazide
This section provides information on the proper use of a number of products that contain methyclothiazide. It may not be specific to Enduron. Please read with care.
In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .
Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .
Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to receive it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .
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 forms (tablets):
- For fluid retention (edema):
- Adults—The usual dose is 2.5 to 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For high blood pressure:
- Adults—The usual dose is 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For fluid retention (edema):
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 Enduron
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .
Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions or seizures; decreased urine; drowsiness; dry mouth; excessive thirst; muscle pains or cramps; nausea or vomiting; increased heart rate or pulse; or unusual tiredness or weakness. These may be symptoms of a condition called hypokalemia or potassium loss .
This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy.
Drinking alcoholic beverages may also make the dizziness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink .
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (e.g., tests for parathyroid function) may be affected by this medicine .
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .
Enduron 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:
Incidence not known
- Abdominal or stomach pain
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of skin
- bloating
- blood in urine or stools
- bloody urine
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- clay-colored stools
- cloudy urine
- cold sweats
- confusion
- constipation
- cough or hoarseness
- coughing that sometimes produces a pink frothy sputum
- coughing up blood
- cracks in the skin
- darkened urine
- decrease in urine output or decrease in urine-concentrating ability
- decreased frequency or amount of urine
- diarrhea
- difficult, fast, or noisy breathing, sometimes with wheezing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- dry mouth
- fast or irregular heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- general body swelling
- general feeling of discomfort or illness
- general feeling of tiredness or weakness
- greatly decreased frequency of urination or amount of urine
- headache
- hives
- increased blood pressure
- increased hunger
- increased sweating
- increased thirst
- increased urination
- indigestion
- itching
- joint pain, stiffness, or swelling
- loss of appetite
- loss of heat from the body
- lower back or side pain
- muscle cramps or pain
- nausea or vomiting
- nosebleeds
- numbness, tingling, pain, or weakness in hands or feet
- pain in joints or muscles
- painful or difficult urination
- pains in stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- red, irritated eyes
- red skin lesions, often with a purple center
- red, swollen skin
- redness, soreness, or itching skin
- scaly skin
- seizures
- shortness of breath
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- sores, welting or blisters
- sugar in the urine
- swelling of face, fingers, legs, ankles, feet, or lower legs
- swollen or painful glands
- tenderness of salivary glands
- thickening of bronchial secretions
- tightness in chest
- trembling
- troubled breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight loss
- vomiting of blood
- weakness and heaviness of legs
- weight gain
- wheezing
- 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:
Incidence not known
- Cramping
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- feeling of constant movement of self or surroundings
- hair loss, thinning of hair
- inability to have or keep an erection
- increased sensitivity of skin to sunlight
- loss in sexual ability, desire, drive, or performance
- muscle spasm
- pinpoint red or purple spots on skin
- redness or other discoloration of skin
- restlessness
- sensation of spinning
- severe sunburn
- weakness
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: Enduron 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 Enduron resources
- Enduron Side Effects (in more detail)
- Enduron Use in Pregnancy & Breastfeeding
- Drug Images
- Enduron Drug Interactions
- Enduron Support Group
- 0 Reviews for Enduron - Add your own review/rating
- Methyclothiazide MedFacts Consumer Leaflet (Wolters Kluwer)
- Methyclothiazide Prescribing Information (FDA)
- Aquatensen Concise Consumer Information (Cerner Multum)
Compare Enduron with other medications
- Edema
- High Blood Pressure
Subscribe to:
Comments (Atom)