Ondeton may be available in the countries listed below.
Ondansetron hydrochloride dihydrate (a derivative of Ondansetron) is reported as an ingredient of Ondeton in the following countries:
International Drug Name Search
Omaflaxina may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Omaflaxina in the following countries:
International Drug Name Search
Generic Name: loperamide (loe PER a mide)
Brand Names: Diamode, Imodium A-D, Imodium A-D EZ Chews, Imodium A-D New Formula, Kao-Paverin, Kaopectate 1-D, Maalox Anti-Diarrheal
Loperamide slows the rhythm of digestion so that the small intestines have more time to absorb fluid and nutrients from the foods you eat.
Loperamide is used to treat diarrhea. Loperamide is also used to reduce the amount of stool in people who have an ileostomy (re-routing of the bowel through a surgical opening in the stomach).
Loperamide may also be used for purposes not listed in this medication guide.
Before taking loperamide, tell your doctor if you have a fever, mucus in your stools, a history of liver disease, or if you are taking an antibiotic.
stools that are bloody, black, or tarry; or
if you have diarrhea that is caused by taking an antibiotic.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
a fever;
mucus in your stools;
if you are taking an antibiotic.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Loperamide is usually taken at the first sign of diarrhea, and again if diarrhea comes back. The first dose of loperamide is usually twice as much as the following doses. Do not take this medication more than 3 times in 24 hours without your doctor's advice.
The loperamide chewable tablet must be chewed before swallowing.
Immodium A-D Liquid and New Immodium A-D Liquid contain two different strengths of loperamide. If you switch from using one brand to using the other, follow the dosing instructions carefully. Immodium A-D Liquid also contains a small amount of alcohol, but New Immodium A-D Liquid does not.
Since loperamide is taken as 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.
Overdose symptoms may include dizziness, drowsiness, urinating less than usual, severe stomach cramps or bloating, and vomiting.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you are taking an antibiotic and you have diarrhea that is watery or has blood in it, call your doctor. Do not use loperamide to stop the diarrhea unless your doctor has told you to.
stomach pain or bloating;
ongoing or worsening diarrhea;
diarrhea that is watery or bloody; or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
dizziness;
drowsiness, tired feeling;
constipation;
mild stomach pain; or
mild skin rash or itching.
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.
Tell your doctor about all other medicines you use, especially saquinavir (Invirase).
This list is not complete and other drugs may interact with loperamide. 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.
See also: Kaopectate Caplet side effects (in more detail)
The following drugs and medications are in some way related to, or used in the treatment of Anticholinesterase Poisoning. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Glucosamina may be available in the countries listed below.
Glucosamina (DCIT) is known as Glucosamine in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The following points should be considered when initiating therapy with Kaletra:
Kaletra tablets may be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed.
Kaletra oral solution must be taken with food.
Once daily administration of Kaletra is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].
Kaletra should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].
Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir
[see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]
Kaletra tablets and oral solution should not be administered as a once daily regimen in combination with efavirenz, nevirapine, amprenavir, or nelfinavir.
Kaletra tablets and oral solution should not be administered once daily in pediatric patients < 18 years of age.
Kaletra oral solution should not be administered to neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been attained [see Warnings and Precautions (5.2)].
Kaletra oral solution contains 42.4% (v/v) alcohol and 15.3% (w/v) propylene glycol. Special attention should be given to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, and overdose. This is especially important for infants and young children. Total amounts of alcohol and propylene glycol from all medicines that are to be given to pediatric patients 14 days to 6 months of age should be taken into account in order to avoid toxicity from these excipients [see Warnings and Precautions (5.2) and Overdosage (10)].
Prescribers should calculate the appropriate dose of Kaletra for each individual child based on body weight (kg) or body surface area (BSA) to avoid underdosing or exceeding the recommended adult dose.
Body surface area (BSA) can be calculated as follows:
The Kaletra dose can be calculated based on weight or BSA:
Patient Weight (kg) × Prescribed lopinavir dose (mg/kg) = Administered lopinavir dose (mg)
Patient BSA (m2) × Prescribed lopinavir dose (mg/m2) = Administered lopinavir dose (mg)
If Kaletra oral solution is used, the volume (mL) of Kaletra solution can be determined as follows:
Volume of Kaletra solution (mL) = Administered lopinavir dose (mg) ÷ 80 (mg/mL)
The dose of the oral solution should be administered using a calibrated dosing syringe.
Before prescribing Kaletra 100/25 mg tablets, children should be assessed for the ability to swallow intact tablets. If a child is unable to reliably swallow a Kaletra tablet, the Kaletra oral solution formulation should be prescribed.
In pediatric patients 14 days to 6 months of age, the recommended dosage of lopinavir/ritonavir using Kaletra oral solution is 16/4 mg/kg or 300/75 mg/m2 twice daily. Prescribers should calculate the appropriate dose based on body weight or body surface area.
Because no data exists for dosage when administered with efavirenz, nevirapine, amprenavir, or nelfinavir, it is recommended that Kaletra not be administered in combination with these drugs in patients < 6 months of age.
Without Concomitant Efavirenz, Nevirapine, Amprenavir or Nelfinavir
Dosing recommendations using oral solution
In children 6 months to 18 years of age, the recommended dosage of lopinavir/ritonavir using Kaletra oral solution without concomitant efavirenz, nevirapine, amprenavir, or nelfinavir is 230/57.5 mg/m2 given twice daily, not to exceed the recommended adult dose (400/100 mg [5 mL] twice daily). If weight-based dosing is preferred, the recommended dosage of lopinavir/ritonavir for patients < 15 kg is 12/3 mg/kg given twice daily and the dosage for patients ≥ 15 kg to 40 kg is 10/2.5 mg/kg given twice daily.
Dosing recommendations using tablets
Table 1 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for Kaletra tablets.
| Body Weight (kg) | Body Surface Area (m2)* | Recommended number of 100/25 mg Tablets Twice Daily |
| 15 to 25 | ≥0.6 to < 0.9 | 2 |
| >25 to 35 | ≥0.9 to < 1.4 | 3 |
| >35 | ≥1.4 | 4 (or two 200/50 mg tablets) |
| * Kaletra oral solution is available for children with a BSA less than 0.6 m2 or those who are unable to reliably swallow a tablet. | ||
Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir, or Nelfinavir
Dosing recommendations using oral solution
A dose increase of Kaletra to 300/75 mg/m2 using Kaletra oral solution is needed when co-administered with efavirenz, nevirapine, amprenavir, or nelfinavir in children (both treatment-naïve and treatment-experienced) 6 months to 18 years of age, not to exceed the recommended adult dose (533/133 mg [6.5 mL] twice daily). If weight-based dosing is preferred, the recommended dosage for patients <15 kg is 13/3.25 mg/kg given twice daily and the dosage for patients >15 kg to 45 kg is 11/2.75 mg/kg given twice daily.
Dosing recommendations using tablets
Table 2 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for Kaletra tablets when given in combination with efavirenz, nevirapine, amprenavir, or nelfinavir.
| Body Weight (kg) | Body Surface Area (m2)* | Recommended number of 100/25 mg Tablets Twice Daily |
| 15 to 20 | ≥0.6 to < 0.8 | 2 |
| >20 to 30 | ≥0.8 to < 1.2 | 3 |
| >30 to 45 | ≥1.2 to <1.7 | 4 (or two 200/50 mg tablets) |
| >45 | ≥1.7 | 5 [see Dosage and Administration, Adult Patients (2.1)] |
| * Kaletra oral solution is available for children with a BSA less than 0.6 m2 or those who are unable to reliably swallow a tablet. † Please refer to the individual product labels for appropriate dosing in children. | ||
| Drug Class | Drugs Within Class That Are Contraindicated With Kaletra | Clinical comments |
| Alpha 1- Adrenoreceptor antagonist | Alfuzosin | Potentially increased alfuzosin concentrations can result in hypotension. |
| Antimycobacterial | Rifampin | May lead to loss of virologic response and possible resistance to Kaletra or to the class of protease inhibitors or other co-administered antiretroviral agents [see Drug Interactions (7)]. |
| Ergot Derivatives | Dihydroergotamine, ergonovine, ergotamine, methylergonovine | Potential for acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues. |
| GI motility agent | Cisapride | Potential for cardiac arrhythmias. |
| Herbal Products | St. John's Wort (hypericum perforatum) | May lead to loss of virologic response and possible resistance to Kaletra or to the class of protease inhibitors. |
| HMG-CoA Reductase Inhibitors | Lovastatin, simvastatin | Potential for myopathy including rhabdomyolysis. |
| PDE5 enzyme inhibitor | Sildenafila (Revatio®) when used for the treatment of pulmonary arterial hypertension | A safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope [see Drug Interactions (7)]. |
| Neuroleptic | Pimozide | Potential for cardiac arrhythmias. |
| Sedative/Hypnotics | Triazolam; orally administered midazolamb | Prolonged or increased sedation or respiratory depression. |
| a see Drug Interactions (7) for coadministration of sildenafil in patients with erectile dysfunction. bsee Drug Interactions, Table 9 for parenterally administered midazolam. | ||
Kaletra is a CYP3A inhibitor. Initiating treatment with Kaletra in patients receiving medications metabolized by CYP3A or initiating medications metabolized by CYP3A in patients already maintained on Kaletra may result in increased plasma concentrations of concomitant medications. Higher plasma concentrations of concomitant medications can result in increased or prolonged therapeutic or adverse effects, potentially leading to severe, life-threatening or fatal events. The potential for drug-drug interactions must be considered prior to and during therapy with Kaletra. Review of other medications taken by patients and monitoring of patients for adverse effects is recommended during therapy with Kaletra.
See Tables 3 and 9 for listing of drugs that are contraindicated for use with Kaletra due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity [see Contraindications (4) and Drug Interactions (7)].
Kaletra oral solution contains the excipients alcohol (42.4% v/v) and propylene glycol (15.3% w/v). When administered concomitantly with propylene glycol, ethanol competitively inhibits the metabolism of propylene glycol, which may lead to elevated concentrations. Preterm neonates may be at increased risk of propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol, thereby leading to accumulation and potential adverse events. Postmarketing life-threatening cases of cardiac toxicity (including complete AV block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving Kaletra oral solution.
Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. A safe and effective dose of Kaletra oral solution in this patient population has not been established. However, if the benefit of using Kaletra oral solution to treat HIV infection in infants immediately after birth outweighs the potential risks, infants should be monitored closely for increases in serum osmolality and serum creatinine, and for toxicity related to Kaletra oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, CNS depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis. Total amounts of alcohol and propylene glycol from all medicines that are to be given to infants should be taken into account in order to avoid toxicity from these excipients [see Dosage and Administration (2.2) and Overdosage (10)].
Pancreatitis has been observed in patients receiving Kaletra therapy, including those who developed marked triglyceride elevations. In some cases, fatalities have been observed. Although a causal relationship to Kaletra has not been established, marked triglyceride elevations are a risk factor for development of pancreatitis [see Warnings and Precautions (5.10)]. Patients with advanced HIV-1 disease may be at increased risk of elevated triglycerides and pancreatitis, and patients with a history of pancreatitis may be at increased risk for recurrence during Kaletra therapy.
Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis occur. Patients who exhibit these signs or symptoms should be evaluated and Kaletra and/or other antiretroviral therapy should be suspended as clinically appropriate.
Patients with underlying hepatitis B or C or marked elevations in transaminase prior to treatment may be at increased risk for developing or worsening of transaminase elevations or hepatic decompensation with use of Kaletra.
There have been postmarketing reports of hepatic dysfunction, including some fatalities. These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications in the setting of underlying chronic hepatitis or cirrhosis. A causal relationship with Kaletra therapy has not been established.
Elevated transaminases with or without elevated bilirubin levels have been reported in HIV-1 mono-infected and uninfected patients as early as 7 days after the initiation of Kaletra in conjunction with other antiretroviral agents. In some cases, the hepatic dysfunction was serious; however, a definitive causal relationship with Kaletra therapy has not been established.
Appropriate laboratory testing should be conducted prior to initiating therapy with Kaletra and patients should be monitored closely during treatment. Increased AST/ALT monitoring should be considered in the patients with underlying chronic hepatitis or cirrhosis, especially during the first several months of Kaletra treatment [see Use In Specific Populations (8.6)].
New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during post-marketing surveillance in HIV-1 infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases, diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between protease inhibitor therapy and these events has not been established.
Lopinavir/ritonavir prolongs the PR interval in some patients. Cases of second or third degree atrioventricular block have been reported. Kaletra should be used with caution in patients with underlying structural heart disease, pre-existing conduction system abnormalities, ischemic heart disease or cardiomyopathies, as these patients may be at increased risk for developing cardiac conduction abnormalities.
The impact on the PR interval of co-administration of Kaletra with other drugs that prolong the PR interval (including calcium channel blockers, beta-adrenergic blockers, digoxin and atazanavir) has not been evaluated. As a result, co-administration of Kaletra with these drugs should be undertaken with caution, particularly with those drugs metabolized by CYP3A. Clinical monitoring is recommended [see Clinical Pharmacology (12.3)].
Postmarketing cases of QT interval prolongation and torsade de pointes have been reported although causality of Kaletra could not be established. Avoid use in patients with congenital long QT syndrome, those with hypokalemia, and with other drugs that prolong the QT interval [see Clinical Pharmacology (12.3)].
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Kaletra. During the initial phase of combination antiretroviral treatment, patients whose immune system responds 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.
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.
Treatment with Kaletra has resulted in large increases in the concentration of total cholesterol and triglycerides [see Adverse Reactions (6.1)]. Triglyceride and cholesterol testing should be performed prior to initiating Kaletra therapy and at periodic intervals during therapy. Lipid disorders should be managed as clinically appropriate, taking into account any potential drug-drug interactions with Kaletra and HMG-CoA reductase inhibitors [see Contraindications (4) and Drug Interactions (7.3)].
Increased bleeding, including spontaneous skin hematomas and hemarthrosis have been reported in patients with hemophilia type A and B treated with protease inhibitors. In some patients additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship between protease inhibitor therapy and these events has not been established.
Because the potential for HIV cross-resistance among protease inhibitors has not been fully explored in Kaletra-treated patients, it is unknown what effect therapy with Kaletra will have on the activity of subsequently administered protease inhibitors [see Clinical Pharmacology (12.4)].
The following adverse reactions are discussed in greater detail in other sections of the labeling.
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety profile of Kaletra in adults is primarily based on 1964 HIV-1 infected patients in clinical trials.
The most common adverse reaction was diarrhea, which was generally of mild to moderate severity. In study 730, the incidence of diarrhea of any severity during 48 weeks of therapy was 60% in patients receiving Kaletra tablets once daily compared to 57% in patients receiving Kaletra tablets twice daily. More patients receiving Kaletra tablets once daily (14, 4.2%) had ongoing diarrhea at the time of discontinuation as compared to patients receiving Kaletra tablets twice daily (6, 1.8%). In study 730, discontinuations due to any adverse reaction were 4.8% in patients receiving Kaletra tablets once daily as compared to 3% in patients receiving Kaletra tablets twice daily. In study 802, the incidence of diarrhea of any severity during 48 weeks of therapy was 50% in patients receiving Kaletra tablets once daily compared to 39% in patients receiving Kaletra tablets twice daily. Moderate or severe drug-related diarrhea occurred in 14% of patients receiving Kaletra tablets once daily as compared to 11% in patients receiving Kaletra tablets twice daily. At the time of discontinuation, 19 (6.3%) patients receiving Kaletra tablets once daily had ongoing diarrhea, as compared to 11 (3.7%) patients receiving Kaletra tablets twice daily. Discontinuations due to any adverse reaction occurred in 4.3% of patients receiving Kaletra tablets once daily compared to 7.0% in patients receiving Kaletra tablets twice daily. In study 863, discontinuations of randomized therapy due to adverse reactions were 3.4% in Kaletra-treated and 3.7% in nelfinavir-treated patients.
Treatment-emergent clinical adverse reactions of moderate or severe intensity in ≥ 2% of patients treated with combination therapy for up to 48 weeks (Studies 863 and 730) and for up to 360 weeks (Study 720) are presented in Table 4 (treatment-naïve patients); and for up to 48 weeks (Studies 888 and 802), 84 weeks (Study 957) and 144 weeks (Study 765) in Table 5 (protease inhibitor-experienced patients).
| Study 863 (48 Weeks) | Study 720 (360 Weeks) | Study 730 (48 Weeks) | |||
| Kaletra 400/100 mg Twice Daily + d4T + 3TC (N = 326) | Nelfinavir 750 mg Three Times Daily + d4T + 3TC (N = 327) | Kaletra Twice Daily2 + d4T + 3TC (N = 100) | Kaletra 800/200 mg Once Daily + TDF +FTC (N=333) | Kaletra 400/100 mg Twice Daily + TDF +FTC (N=331) | |
| Endocrine Disorders | |||||
| Hypogonadism | 0% | 0% | 2% | 0% | 0% |
| Gastrointestinal Disorders | |||||
| Diarrhea | 16% | 17% | 28% | 17% | 15% |
| Nausea | 7% | 5% | 16% | 7% | 5% |
| Vomiting | 2% | 2% | 6% | 3% | 4% |
| Abdominal Pain | 4% | 3% | 11% | 1% | 1% |
| Dyspepsia | 2% | <1% | 6% | 0% | 0% |
| Flatulence | 2% | 1% | 4% | 1% | 1% |
| General Disorders and Administration Site Conditions | |||||
| Asthenia | 4% | 3% | 9% | <1% | <1% |
| Infections and Infestations | |||||
| Bronchitis | 0% | 0% | 2% | 0% | <1% |
| Investigations | |||||
| Weight decreased | 1% | <1% | 2% | 0% | <1% |
| Metabolism and Nutrition Disorders | |||||
| Anorexia | 1% | <1% | 2% | <1% | 1% |
| Musculoskeletal and Connective Tissue Disorders | |||||
| Myalgia | 1% | 1% | 2% | 0% | 0% |
| Nervous System Disorders | |||||
| Headache | 2% | 2% | 6% | 2% | 2% |
| Paresthesia | 1% | 1% | 2% | 0% | 0% |
| Psychiatric Disorders | |||||
| Insomnia | 2% | 1% | 3% | 1% | 0% |
| Depression | 1% | 2% | 0% | 0% | 0% |
| Libido decreased | <1% | <1% | 2% | 0% | <1% |
| Skin and Subcutaneous Tissue Disorders | |||||
| Rash | 1% | 2% | 5% | <1% | 1% |
| Vascular Disorders | |||||
| Vasodilation | 0% | 0% | 3% | 0% | 0% |
| 1 Includes adverse reactions of possible or probable relationship to study drug. 2 Includes adverse reaction data from dose group I (200/100 mg twice daily [N = 16] and 400/100 mg twice daily [N = 16]) and dose group II (400/100 mg twice daily [N = 35] and 400/200 mg twice daily [N = 33]). Within dosing groups, moderate to severe nausea of probable/possible relationship to Kaletra occurred at a higher rate in the 400/200 mg dose arm compared to the 400/100 mg dose arm in group II. Definitions: d4T = Stavudine; 3TC = Lamivudine; TDF = Tenofovir Disoproxil Fumarate; FTC = Emtricitabine | |||||
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | Study 802 (48 Weeks) | |||
| Kaletra 400/100 mg Twice Daily + NVP + NRTIs (N = 148) | Investigator-selected protease inhibitor(s) + NVP + NRTIs (N = 140) | Kaletra Twice Daily + NNRTI + NRTIs (N = 127) | Kaletra 800/200 mg Once Daily +NRTIs (N=300) | Kaletra 400/100 mg Twice Daily + NRTIs (N=299) | |
| Gastrointestinal Disorders | |||||
| Diarrhea | 7% | 9% | 23% | 14% | 11% |
| Nausea | 7% | 16% | 5% | 3% | 7% |
| Vomiting | 4% | 12% | 2% | 2% | 3% |
| Abdominal Pain | 2% | 2% | 4% | 2% | <1% |
| Abdominal Pain Upper | N/A | N/A | N/A | 1% | 2% |
| Dyspepsia | 1% | 1% | 2% | 1% | <1% |
| Flatulence | 1% | 2% | 2% | 1% | 1% |
| Dysphasia | 2% | 1% | 0% | 0% | 0% |
| General Disorders and Administration Site Conditions | |||||
| Asthenia | 3% | 6% | 9% | <1% | <1% |
| Pyrexia | 2% | 1% | 2% | 0% | <1% |
| Chills | 2% | 0% | 0% | 0% | 0% |
| Investigations | |||||
| Weight decreased | 0% | 1% | 3% | <1% | <1% |
| Metabolism and Nutrition Disorders | |||||
| Anorexia | 1% | 3% | 0% | 0% | 1% |
| Musculoskeletal and Connective Tissue Disorders | |||||
| Myalgia | 1% | 1% | 2% | 0% | 0% |
| Nervous System Disorders | |||||
| Headache | 2% | 3% | 2% | <1% | 0% |
| Paresthesia | 0% | 1% | 2% | 0% | 0% |
| Psychiatric Disorders | |||||
| Depression | 1% | 2% | 3% | <1% | 0% |
| Insomnia | 0% | 2% | 2% | 0% | <1% |
| Skin and Subcutaneous Tissue Disorders | |||||
| Rash | 2% | 1% | 2% | 0% | 0% |
| Vascular Disorders | |||||
| Hypertension | 0% | 0% | 2% | 0% | |
Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, cracked skin, calluses). It may also be used for certain other skin or nail conditions as determined by your doctor.
Kerafoam Foam is a debriding agent. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Kerafoam Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Kerafoam Foam. Because little, if any, of Kerafoam Foam is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Kerafoam Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Kerafoam Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Kerafoam Foam.
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:
Mild, temporary burning, itching, irritation, or stinging.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; severe or persistent burning or irritation.
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: Kerafoam side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.
Store Kerafoam Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not freeze. Store upright away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Kerafoam Foam out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Kerafoam Foam. 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.
Generic Name: benzoyl peroxide (Topical route)
BEN-zoe-il per-OX-ide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antiacne Antibacterial
Benzoyl peroxide is used to treat acne.
It may also be used for other conditions as determined by your doctor.
Some of these preparations are 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 these uses are not included in product labeling, benzoyl peroxide is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
For children up to 12 years of age: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of benzoyl peroxide with use in other age groups. For children 12 years of age and older: Although there is no specific information comparing use of benzoyl peroxide in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 12 years of age and older than it does in adults.
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. Although there is no specific information comparing use of benzoyl peroxide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain benzoyl peroxide. It may not be specific to Acne. Please read with care.
It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. To do so may cause irritation of the skin.
Do not use this medicine in or around the eyes or lips, or inside the nose, or on sensitive areas of the neck. Spread the medicine away from these areas when applying. If the medicine gets on these areas, wash with water at once.
Do not apply this medicine to windburned or sunburned skin or on open wounds, unless otherwise directed by your doctor.
This medicine usually comes with patient directions. Read them carefully before using the medicine.
To use the cream, gel, lotion, or stick form of benzoyl peroxide:
To use the shave cream form of benzoyl peroxide:
To use the cleansing bar, cleansing lotion, or soap form of benzoyl peroxide:
To use the facial mask form of benzoyl peroxide:
After applying the medicine, wash your hands to remove any medicine that might remain on them.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply 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.
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.
During the first 3 weeks you are using benzoyl peroxide, your skin may become irritated. Also, your acne may seem to get worse before it gets better. If your skin problem has not improved within 4 to 6 weeks, check with your health care professional.
You should not wash the areas of the skin treated with benzoyl peroxide for at least 1 hour after application.
Avoid using any other topical medicine on the same area within 1 hour before or after using benzoyl peroxide. Otherwise, benzoyl peroxide may not work properly.
Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as benzoyl peroxide:
Using these products along with benzoyl peroxide may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it doesn't cause a problem with any other topical products that you might use during the day. Check with your doctor before using any other topical medicines with benzoyl peroxide.
This medicine may bleach hair or colored fabrics.
Check with your doctor at any time your skin becomes too dry or irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation.
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 as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Acne Topical 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.
Ketoconazole Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established.
Ketoconazole Foam, 2% should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense Ketoconazole Foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Ketoconazole Foam, 2% with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Ketoconazole Foam, 2% may be applied directly to the skin (rather than on the hair).
Avoid contact with the eyes and other mucous membranes. Ketoconazole Foam, 2% is not for ophthalmic, oral or intravaginal use.
Ketoconazole Foam, 2% contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers.
None
Ketoconazole Foam, 2% may result in contact sensitization, including photoallergenicity. [See Adverse Reactions (6.2)]
The contents of Ketoconazole Foam, 2% include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).
Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.
The safety data presented in Table 1 (below) reflect exposure to Ketoconazole Foam, 2% in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Ketoconazole Foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.
Application site reactions that were reported in ≤1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth.
In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Ketoconazole Foam, 2%. Ketoconazole Foam, 2% may cause contact sensitization.
Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (4.8 times the maximum expected human topical dose based on a mg/m2 comparison, assuming 100% absorption from 8 g of foam). However, these effects may be partly related to maternal toxicity, which was also observed at this dose level. [See Pharmacokinetics (12.3)]
No reproductive studies in animals have been performed with Ketoconazole Foam, 2%.
There are no adequate and well-controlled studies of Ketoconazole Foam, 2% in pregnant women. Ketoconazole Foam, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Ketoconazole Foam, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Ketoconazole Foam, 2% is administered to women who are breastfeeding.
The safety and effectiveness of Ketoconazole Foam, 2% in pediatric patients less than 12 years of age have not been established.
Of the 672 subjects treated with Ketoconazole Foam, 2% in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14)]
Of the 672 subjects treated with Ketoconazole Foam, 2% in the clinical trials, 107 (16%) were 65 years and over.
Ketoconazole Foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.
The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-1-ylmethyl)-1, 3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28CI2N4O4 and a molecular weight of 531.43.
The following is the chemical structure:
Ketoconazole Foam, 2% contains 20 mg ketoconazole USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.
The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.
The pharmacodynamics of Ketoconazole Foam, 2% has not been established.
In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of Ketoconazole Foam, 2% twice daily for 4 weeks. Circulating plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject.
Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur. The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.
Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of Ketoconazole Foam, 2%.
In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the expected topical dose in humans based on a mg/m2 comparison. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential.
At oral dose levels of 75 mg/kg/day (4.5 times the expected topical human dose in mg/m2), ketoconazole impaired reproductive performance and fertility when administered to male rats (increased abnormal sperm, decreased sperm mobility and decreased pregnancy in mated females).
The safety and efficacy of Ketoconazole Foam, 2% were evaluated in a randomized, double-blind, vehicle-controlled study in subjects 12 years and older with mild to severe seborrheic dermatitis. In the study, 427 subjects received Ketoconazole Foam, 2% and 420 subjects received vehicle foam. Subjects applied Ketoconazole Foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale.
Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.
Ketoconazole Foam, 2% is supplied in 50 g (NDC 45802-532-32) and 100 g (NDC 45802-532-33) aluminum containers.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not store under refrigerated conditions.Do not expose containers to heat, and/or store at temperatures above 120°F (49°C). Do not store in direct sunlight.
Contents are flammable.
Contents under pressure. Do not puncture and/or incinerate container.
Keep out of reach of children.
See FDA-approved patient labeling. (17.3)
• Avoid fire, flame and/or smoking during and immediately following application.
• Do not apply Ketoconazole Foam, 2% directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.
• Ketoconazole Foam, 2% may cause skin irritation (application site burning and/or reactions)
• Ketoconazole Foam, 2% may cause contact sensitization.
• As with any topical medication, patients should wash their hands after application.
• Inform a physician if the area of application shows signs of increased irritation and report any signs of adverse reactions.
- See below -
Ketoconazole Foam, 2%
IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.
Read the Patient Information that comes with Ketoconazole Foam, 2% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
What is Ketoconazole Foam, 2%?
Ketoconazole Foam, 2% is used on the skin (topical) to treat a skin condition called seborrheic dermatitis in patients 12 years and older. Seborrheic dermatitis can cause areas of flaky skin (scales) on the scalp, face, ears, chest or upper back.
Ketoconazole Foam, 2% has not been studied in children less than 12 years old.
What should I tell my doctor before using Ketoconazole Foam, 2%?
For female patients, tell your doctor if you:
• are pregnant or become pregnant. It is not known if Ketoconazole Foam, 2% can harm a fetus (unborn baby).
• breastfeeding. It is not known if Ketoconazole Foam, 2% passes into breast milk.
How should I use Ketoconazole Foam, 2%?
• Apply Ketoconazole Foam, 2% exactly as prescribed. Ketoconazole Foam, 2% is usually applied to the affected skin areas two times a day (once in the morning and once at night) for 4 weeks. Talk to your doctor if your skin does not improve after 4 weeks of treatment with Ketoconazole Foam, 2%.
• Keep the Ketoconazole Foam, 2% can away from and do not spray it near fire, open flame, or direct heat. Ketoconazole Foam, 2% is flammable. Never throw the Ketoconazole Foam, 2% can into a fire, even if the can is empty.
Instructions for applying Ketoconazole Foam, 2%
1. Hold the can at an upright angle. 2. Push the button to spray Ketoconazole Foam, 2% directly into the cap of the can or other cool surface. Spray only the amount of Ketoconazole Foam, 2% that you will need to cover your affected skin. Do not spray Ketoconazole Foam, 2% directly onto your affected skin or your hands because the foam will begin to melt right away when it touches your skin. 3. If your fingers are warm, rinse them in cold water first. Be sure to dry them well before handling the Ketoconazole Foam, 2%. If the Ketoconazole Foam, 2% can seems warm or the foam seems runny, place the can under cool running water for a few minutes. 4. Using your fingertips, gently massage Ketoconazole Foam, 2% into the affected areas until the foam disappears. 5. If you are treating skin areas with hair such as your scalp, move any hair away so that the foam can be applied to the affected skin. 6. Do not get Ketoconazole Foam, 2% in your eyes, mouth or vagina. If any Ketoconazole Foam, 2% gets in your eyes, mouth or vagina, rinse areas well with water. 7. Wash your hands well after applying Ketoconazole Foam, 2%. | |
What are the possible side effects of Ketoconazole Foam, 2%?
The most common side effects of Ketoconazole Foam, 2% are reaction or burning on treated skin areas. Tell your doctor if you have any reaction on your treated skin such as redness, itching, or a rash. These are not all the side effects of Ketoconazole Foam, 2%. Ask your doctor or pharmacist for more information.
How should I store Ketoconazole Foam, 2%?
• Ketoconazole Foam, 2% is flammable.
• Do not spray Ketoconazole Foam, 2% near fire or direct heat. Never throw the can into a fire, even if the can is empty.
• Store the can of Ketoconazole Foam, 2% at room temperature, 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not place the Ketoconazole Foam, 2% can in the refrigerator or freezer.
• Keep the Ketoconazole Foam, 2% can away from all sources of fire and heat. Do not leave the Ketoconazole Foam, 2% can in direct sunlight.
• Do not smoke while holding the Ketoconazole Foam, 2% can or while spraying or applying the foam.
• Do not pierce or burn the Ketoconazole Foam, 2% can.
• Keep Ketoconazole Foam, 2% and all medicines out of the reach of children.
General information about Ketoconazole Foam, 2%
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Ketoconazole Foam, 2% for any other condition for which it was not prescribed. Do not give Ketoconazole Foam, 2% to other people, even if they have the same condition that you have. It may harm them.
This leaflet summarizes the most important information about Ketoconazole Foam, 2%. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ketoconazole Foam, 2% that is written for health professionals.
What are the ingredients in Ketoconazole Foam, 2%?
Active ingredient: ketoconazole, USP
Inactive Ingredients: cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.
This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
The Patient Information leaflet was last revised: August 2010
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Rx Only
Made in Israel
Manufactured by Perrigo
Yeruham 80500, Israel
Distributed By
Perrigo®
Allegan, MI 49010 • www.perrigo.com
Rev. 08/2010
5K200 RC J1
Rx Only
Ketoconazole Foam, 2%
For Topical Use Only.
Not For Ophthalmic, Oral, or Intravaginal Use.
Ketoconazole Foam, 2% Carton Image 1
Ketoconazole Foam, 2% Carton Image 2
Rx Only
Ketoconazole Foam, 2%
For Topical Use Only.
Not For Ophthalmic, Oral, or Intravaginal Use.
Ketoconazole Foam, 2% Label
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA091550 | 08/30/2011 | |
| Labeler - Perrigo New York Inc (078846912) |
