Dozept may be available in the countries listed below.
Donepezil hydrochloride (a derivative of Donepezil) is reported as an ingredient of Dozept in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Marbofloxacin is reported as an ingredient of Zeniquin in the following countries:
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Generic Name: Methocarbamol
Class: Centrally Acting Skeletal Muscle Relaxants
VA Class: MS200
Chemical Name: 1-Carbamate-3-(2-methoxyphenoxy)-1,2-propanediol
Molecular Formula: C11H15NO5
CAS Number: 532-03-6
Centrally acting skeletal muscle relaxant.b
Adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.a b c
For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).h i j k l m
Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.h i j k l m
Various skeletal muscle relaxants appear to have comparable efficacy for low back pain reliefg h and are more effective than placebo.h j l
Initially, symptomatic control of acute low back pain focuses on providing sufficient comfort to allow maximum possible activity while awaiting spontaneous recovery; later, as aid to overcome specific activity intolerance.l
Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish;l improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.k
Ineffective in the treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders (e.g., cerebral palsy) and other dyskinesias.b
Has been used as an adjunct to debridement, tetanus antitoxin, penicillin, tracheotomy, fluid and electrolyte replacement, and supportive therapy in the management of tetanus.b However, most authorities prefer other sedatives or muscle relaxants (e.g., diazepam) and, in severe cases, neuromuscular blocking agents.b
Administer orally; may administer IV or IM when oral administration is not feasible or for severe musculoskeletal pain.a b c Do not administer sub-Q.b
Switch from parenteral to oral therapy as soon as possible.b
For administration via NG tube, crush tablets and suspend in water or saline solution.b c
For solution compatibility information, see Compatibility under Stability.
Administer by direct IV injection or by IV infusion.b c
Patient should be recumbent during and for 10–15 minutes following IV administration.b
Avoid extravasation; solution is hypertonic.b c
For direct IV use, inject undiluted solution slowly to minimize adverse effects.b c
Blood aspirated into syringe does not mix with methocarbamol injection; either inject any blood in the syringe or stop the injection when the plunger reaches the blood.b c
For IV infusion, dilute 1 g with up to 250 mL of 5% dextrose or 0.9% sodium chloride injection.b c
Visually inspect diluted solutions for haze prior to administration.b (See Stability.)
For direct IV injection, maximum rate of 300 mg (3 mL of 10% injection) per minute.b c Some clinicians have recommended injection at rate of 180 mg/m2 per minute in children.b
Administer no more than 500 mg (5 mL of 10% injection) into each gluteal region.b c
Children ≥12 years of age: Recommended minimum initial dose is 15 mg/kg or 500 mg/m2; give additional doses of 15 mg/kg or 500 mg/m2 by direct IV injection or IV infusion every 6 hours, if necessary (maximum 1.8 g/m2 daily for 3 consecutive days).b c
Usual initial dosage is 1.5 g 4 times daily for 2–3 days.a b For maintenance, decrease dosage to 4–4.5 g daily in 3–6 divided doses.a b
A few patients may require initial dosage of 8 g daily in divided doses.a b
Usually, 1 g as a single dose, followed by oral methocarbamol to maintain relief.b c
For more severe conditions or when oral administration is not feasible, 1 g every 8 hours (maximum 3 g daily for 3 consecutive days).b c If necessary, may readminister IV or IM after a 2-day drug-free interval.a c
Usual initial dose is 1–2 g by direct IV injection; may administer additional 1–2 g by IV infusion (for maximum total initial dose of 3 g).b c
Repeat IV infusion of 1–2 g every 6 hours until NG tube can be inserted.b c Up to 24 g daily (via NG tube) may be required.b c
Maximum 1.8 g/m2 daily for 3 consecutive days.b c
Maximum 3 g daily for 3 consecutive days.b c
Injection contraindicated in patients with impaired renal function.b c (See Renal Impairment under Cautions.)
Known hypersensitivity to methocarbamol or any ingredient in the formulation.a b c
Performance of activities requiring mental alertness or physical coordination may be impaired.a b c
Possible additive effect with other CNS depressants and/or alcohol.a b c (See Specific Drugs and Laboratory Tests under Interactions.)
Anaphylactic reactions, urticaria, pruritus, rash, skin eruptions, and conjunctivitis with nasal congestion have occurred.a b c
The stopper of the methocarbamol injection (Robaxin) vial contains dry natural rubber (latex).c Some individuals may be hypersensitive to natural latex proteins.c d e f Take appropriate precautions if injection is handled by or administered to individuals with a history of latex sensitivity.c
Use IV or IM with caution, if at all, in patients with known or suspected epilepsy.b c
Category C.a b c
Distributed into milk in dogs; not known whether distributed into human milk.a b c Use caution.a b c
Safety and efficacy (other than IV use in the management of tetanus) not established in children.a b c
Polyethylene glycol vehicle of methocarbamol injection may be irritating to the kidneys; may worsen preexisting acidosis and urea retention.b c Do not administer to patients with impaired renal function.b c
Drowsiness, dizziness, lightheadedness.a b c
Drug or Test | Interaction | Comments |
|---|---|---|
Anticholinesterase agents (e.g., pyridostigmine) | Potential for severe weaknessa b c | Use with caution in patients with myasthenia gravisa b c |
CNS depressants (e.g., alcohol) | Potential for additive CNS depressiona b c | Use caution to avoid overdosagea b c |
Tests for 5-hydroxyindolacetic acid (5-HIAA) in urine (nitrosonaphthol reagent in quantitative method of Udenfriend) | False-positive results (color interference) a b c | |
Tests for vanillylmandelic acid (VMA) in urine by the screening method of Gitlow | False-positive results (color interference)a b c |
Rapidly and almost completely absorbed following oral administration.b
Usually within 30 minutes following oral administration.b
Almost immediate after IV administration.b
Widely distributed in dogs, with highest concentrations in the kidney and liver.b
Methocarbamol and/or its metabolites cross the placenta in dogs.b
Distributed into milk in dogs; not known whether distributed into human milk.a b c
46–50%.a c
Extensively metabolized, presumably in the liver, by dealkylation and hydroxylation.b
Eliminated principally in urine as metabolites (40–50% as glucuronide and sulfate conjugates, remainder as unidentified metabolites); small amount (10–15%) eliminated unchanged in urine.b Very small amounts excreted in feces.b
0.9–1.8 hours.b
In geriatric patients, half-life slightly prolonged.a c
In patients with renal impairment on maintenance dialysis, clearance decreased by 40% but no apparent increase in half-life.a c
In patients with cirrhosis secondary to alcohol abuse, clearance decreased by 70% and half-life increased to about 3.4 hours.a c
Tight containers at 20–25°C.a
20–25°C (may be exposed to 15–30°C).b c Do not freeze.b
Do not refrigerate after dilution (see Compatibility under Stability).b c
For information on systemic interactions resulting from concomitant use, see Interactions.
Precipitation and haze formation may occur if diluted solution is refrigerated.b c
Haze formation in diluted solutions may be unpredictable; visually inspect all diluted solutions prior to administration regardless of storage conditions.b
Compatible |
|---|
Dextrose 5% in waterc |
Sodium chloride 0.9%c |
CNS depressant with sedative and skeletal muscle relaxant effects.a b c
Precise mechanism of action is not known; does not directly relax skeletal muscle and has minimal skeletal muscle relaxant effects.a b c Beneficial effect probably is related to the drug’s sedative effect.a b c
Unlike neuromuscular blocking agents, does not depress neuronal conduction, neuromuscular transmission, or muscle excitability.b
Potential to impair mental alertness or physical coordination, especially with concomitant use of alcohol or other CNS depressants; use caution when driving or operating machinery.a b c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a b c
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 500 mg* | Methocarbamol Tablets | Global, Sandoz, United Research, Watson, West-Ward |
750 mg* | Methocarbamol Tablets | Global, Sandoz, United Research, Watson, West-Ward | ||
Tablets, film-coated | 500 mg | Robaxin (with povidone and propylene glycol) | Schwarz | |
750 mg | Robaxin (with povidone and propylene glycol) | Schwarz | ||
Parenteral | Injection | 100 mg/mL | Robaxin (with 50% polyethylene glycol 300) | Baxter |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Methocarbamol 500MG Tablets (QUALITEST): 60/$14.97 or 120/$23.94
Robaxin 500MG Tablets (ACTIENT PHARMACEUTICALS): 30/$59.99 or 90/$149.96
Robaxin-750 750MG Tablets (ACTIENT PHARMACEUTICALS): 30/$75.99 or 90/$200.98
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
a. Schwarz Pharma. Robaxin and Robaxin-750 tablets prescribing information. Milwaukee, WI; 2003 Apr.
b. AHFS Drug Information 2004. McEvoy GK, ed. Methocarbamol. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 1336-7.
c. Baxter. Robaxin injection prescribing information. Deerfield, IL; 2003 Nov.
d. Food and Drug Administration. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1998; 63:50660-704.
e. Food and Drug Administration. Latex-containing devices; user labeling. 21 CFR Part 801. Proposed rule. (Docket No. 96N-0119) Fed Regist. 1996; 61:32617-21.
f. Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1997; 62:51021-30.
g. McNeil. Cyclobenzaprine hydrochloride (Flexeril) tablets prescribing information. Fort Washington, PA: 2003 Feb.
h. van Tulder MW, Touray T, Furlan AD et al. Muscle relaxants for non-specific low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.
i. van Tulder MW, Scholten RJPM, Kowes BW, et al. Non-steroidal anti-inflammatory drugs for low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.
j. Department of Veterans Affairs Veterans Health Administration Office of Quality & Performance. Management of Person with Low Back Pain/Sciatica in Primary Care. From the web site (). Accessed 8/25/2003.
k. Agency for Healthcare Research and Quality. Adult low back pain. From the National Guideline Clearinghouse website. (). Accessed 8/25/2003.
l. U.S. Department of Health and Human Services. Public Health Service. Agency for Halath Care Policy and Research. Acute low back problems in adults. Clinical Practice Guideline.1994; No. 14
m. U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research. Acute low back problems in adults: Assessment and treatment. Clinical Practice Guideline. Quick Reference Guide for Clinicians.1994; No. 14
There are currently no drugs listed for "Episcleritis".
Definition of Episcleritis: Episcleritis is an inflammation (irritation and swelling) of the episclera, a membrane covering the sclera of the eye.
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Definition of Tinea Versicolor: A chronicfungal infection of the skin. More...
The following drugs and medications are in some way related to, or used in the treatment of Tinea Versicolor. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
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Cimetidine Sandoz may be available in the countries listed below.
Cimetidine is reported as an ingredient of Cimetidine Sandoz in the following countries:
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Lisinopril+Hydroclorothiazide Generics may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Lisinopril+Hydroclorothiazide Generics in the following countries:
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisinopril+Hydroclorothiazide Generics in the following countries:
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Reyataz® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks duration in antiretroviral-treatment-experienced adult and pediatric patients at least 6 years of age.
The following points should be considered when initiating therapy with Reyataz:
General Dosing Recommendations:
Table 1 summarizes the recommended Reyataz dosing regimen in adults. All Reyataz dosing regimens are to be administered as a single dose with food.
| Treatment-Naive Patients | Reyataz 300 mg with ritonavir 100 mg once daily |
| If unable to tolerate ritonavir | Reyataz 400 mg once daily |
| When combined with any of the following: Tenofovir H2-receptor antagonist Proton-pump inhibitor | Reyataz 300 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. • If unable to tolerate ritonavir, administer Reyataz 400 mg once daily at least 2 hours before and at least 10 hours after the H2-receptor antagonist. No single dose of the H2-receptor antagonist should exceed a dose comparable to famotidine 20 mg and the total daily dose should not exceed a dose comparable to famotidine 40 mg. • The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg daily and must be taken approximately 12 hours prior to Reyataz and ritonavir. | |
| When combined with efavirenz | Reyataz 400 mg with ritonavir 100 mg once daily |
| • Efavirenz should be administered on an empty stomach, preferably at bedtime. | |
| Treatment-Experienced Patients | Reyataz 300 mg with ritonavir 100 mg once daily |
| Do not coadminister with proton-pump inhibitors or efavirenz in treatment-experienced patients. | |
| When given with an H2-receptor antagonist | Reyataz 300 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. | |
| When given with both tenofovirand an H2-receptor antagonist | Reyataz 400 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. | |
[For these drugs and other antiretroviral agents for which dosing modification may be appropriate, see Drug Interactions (7).]
The recommended daily dosage of Reyataz for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. Reyataz Capsules must be taken with food. The data are insufficient to recommend dosing of Reyataz for any of the following: (1) patients less than 6 years of age, (2) without ritonavir in any pediatric patient less than 13 years of age, and (3) patients less than 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors.
The recommended dosage of Reyataz with ritonavir in pediatric patients at least 6 years of age is shown in Table 2.
| Body Weight | Reyataz dose | ritonavir dose |
|---|---|---|
| a The Reyataz and ritonavir dose should be taken once daily with food. | ||
| 15 kg to less than 20 kg | 150 mg | 100 mg |
| 20 kg to less than 40 kg | 200 mg | 100 mg |
| at least 40 kg | 300 mg | 100 mg |
For treatment-naive patients at least 13 years of age and at least 40 kg, who are unable to tolerate ritonavir, the recommended dose is Reyataz 400 mg (without ritonavir) once daily with food. For patients at least 13 years of age and at least 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors, Reyataz should not be administered without ritonavir.
Dosing During Pregnancy and the Postpartum Period:
For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for Reyataz. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive Reyataz 300 mg with ritonavir 100 mg. Reyataz should not be administered to HIV-treatment-experienced patients with end stage renal disease managed with hemodialysis. [See Use in Specific Populations (8.7).]
Reyataz should be used with caution in patients with mild-to-moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not experienced prior virologic failure, a dose reduction to 300 mg once daily should be considered. Reyataz should not be used in patients with severe hepatic impairment (Child-Pugh Class C). Reyataz/ritonavir has not been studied in subjects with hepatic impairment and is not recommended. [See Warnings and Precautions (5.5) and Use in Specific Populations (8.8).]
Reyataz (atazanavir sulfate) is contraindicated:
| Drug Class | Drugs within class that are contraindicated with Reyataz | Clinical Comment |
|---|---|---|
| a See Drug Interactions, Table 13 (7) for parenterally administered midazolam. | ||
| b See Drug Interactions, Table 13 (7) for sildenafil when dosed as VIAGRA® for erectile dysfunction. | ||
| Alpha 1-Adrenoreceptor Antagonist | Alfuzosin | Potential for increased alfuzosin concentrations, which can result in hypotension. |
| Antimycobacterials | Rifampin | Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance. |
| Antineoplastics | Irinotecan | Atazanavir inhibits UGT1A1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. |
| Benzodiazepines | Triazolam, orally administered midazolama | Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with Reyataz may cause large increases in the concentration of these benzodiazepines. Potential for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression. |
| Ergot Derivatives | Dihydroergotamine, ergotamine, ergonovine, methylergonovine | Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues. |
| GI Motility Agent | Cisapride | Potential for serious and/or life-threatening reactions such as cardiac arrhythmias. |
| Herbal Products | St. John’s wort (Hypericum perforatum) | Patients taking Reyataz should not use products containing St. John’s wort because coadministration may be expected to reduce plasma concentrations of atazanavir. This may result in loss of therapeutic effect and development of resistance. |
| HMG-CoA Reductase Inhibitors | Lovastatin, simvastatin | Potential for serious reactions such as myopathy including rhabdomyolysis. |
| Neuroleptic | Pimozide | Potential for serious and/or life-threatening reactions such as cardiac arrhythmias. |
| PDE5 Inhibitor | Sildenafilb when dosed as REVATIO® for the treatment of pulmonary arterial hypertension | A safe and effective dose in combination with Reyataz has not been established for sildenafil (REVATIO®) when used for the treatment of pulmonary hypertension. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope). |
| Protease Inhibitors | Indinavir | Both Reyataz and indinavir are associated with indirect (unconjugated) hyperbilirubinemia. |
See Table 3 for a listing of drugs that are contraindicated for use with Reyataz due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity. [See Contraindications (4).] Please refer to Table 13 for established and other potentially significant drug interactions [see Drug Interactions (7.3)].
Atazanavir has been shown to prolong the PR interval of the electrocardiogram in some patients. In healthy volunteers and in patients, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. There have been reports of second-degree AV block and other conduction abnormalities [see Adverse Reactions (6.4) and Overdosage (10)]. In clinical trials that included electrocardiograms, asymptomatic first-degree AV block was observed in 5.9% of atazanavir-treated patients (n=920), 5.2% of lopinavir/ritonavir-treated patients (n=252), 10.4% of nelfinavir-treated patients (n=48), and 3.0% of efavirenz-treated patients (n=329). In Study AI424-045, asymptomatic first-degree AV block was observed in 5% (6/118) of atazanavir/ritonavir-treated patients and 5% (6/116) of lopinavir/ritonavir-treated patients who had on-study electrocardiogram measurements. Because of limited clinical experience in patients with preexisting conduction system disease (eg, marked first-degree AV block or second- or third-degree AV block), atazanavir should be used with caution in these patients. [See Clinical Pharmacology (12.2).]
Atazanavir in combination with diltiazem increased diltiazem plasma concentration by 2-fold with an additive effect on the PR interval. When used in combination with atazanavir, a dose reduction of diltiazem by one-half should be considered and ECG monitoring is recommended. In a pharmacokinetic study between atazanavir 400 mg once daily and atenolol 50 mg once daily, no clinically significant additive effect of atazanavir and atenolol on the PR interval was observed. Dose adjustment of atenolol is not required when used in combination with atazanavir. [See Drug Interactions (7) and Clinical Pharmacology (12.2).] Pharmacokinetic studies between atazanavir and other drugs that prolong the PR interval including beta blockers [other than atenolol, see Drug Interactions (7)], verapamil, and digoxin have not been performed. An additive effect of atazanavir and these drugs cannot be excluded; therefore, caution should be exercised when atazanavir is given concurrently with these drugs, especially those that are metabolized by CYP3A (eg, verapamil).
In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20% of patients treated with Reyataz. The median time to onset of rash in clinical studies was 7.3 weeks and the median duration of rash was 1.4 weeks. Rashes were generally mild-to-moderate maculopapular skin eruptions. Treatment-emergent adverse reactions of moderate or severe rash (occurring at a rate of ≥2%) are presented for the individual clinical studies [see Adverse Reactions (6.1)]. Dosing with Reyataz was often continued without interruption in patients who developed rash. The discontinuation rate for rash in clinical trials was <1%. Reyataz should be discontinued if severe rash develops. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions have been reported in patients receiving Reyataz. [See Contraindications (4).]
Most patients taking Reyataz experience asymptomatic elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT). This hyperbilirubinemia is reversible upon discontinuation of Reyataz. Hepatic transaminase elevations that occur with hyperbilirubinemia should be evaluated for alternative etiologies. No long-term safety data are available for patients experiencing persistent elevations in total bilirubin >5 times ULN. Alternative antiretroviral therapy to Reyataz may be considered if jaundice or scleral icterus associated with bilirubin elevations presents cosmetic concerns for patients. Dose reduction of atazanavir is not recommended since long-term efficacy of reduced doses has not been established. [See Adverse Reactions (6.1, 6.2).]
Caution should be exercised when administering Reyataz to patients with hepatic impairment because atazanavir concentrations may be increased. [See Dosage and Administration (2.5).] Patients with underlying hepatitis B or C viral infections or marked elevations in transaminases before treatment may be at increased risk for developing further transaminase elevations or hepatic decompensation. In these patients, hepatic laboratory testing should be conducted prior to initiating therapy with Reyataz and during treatment. [See Adverse Reactions (6.3) and Use in Specific Populations (8.8).]
Cases of nephrolithiasis were reported during postmarketing surveillance in HIV-infected patients receiving Reyataz therapy. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of therapy may be considered. [See Adverse Reactions (6.4).]
New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported during postmarketing surveillance in HIV-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. [See Adverse Reactions (6.4).]
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Reyataz. 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 jiroveci pneumonia, 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.
There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, 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.
Various degrees of cross-resistance among protease inhibitors have been observed. Resistance to atazanavir may not preclude the subsequent use of other 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 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.
Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
The safety profile of Reyataz in treatment-naive adults is based on 1625 HIV-1 infected patients in clinical trials. 536 patients received Reyataz 300 mg with ritonavir 100 mg and 1089 patients received Reyataz 400 mg or higher (without ritonavir).
The most common adverse reactions are nausea, jaundice/scleral icterus, and rash.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-naive patients receiving combination therapy including Reyataz 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) are presented in Tables 4 and 5, respectively.
| 96 weeksc | 96 weeksc | |
|---|---|---|
| Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined | lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined | |
| (n=441) | (n=437) | |
| * None reported in this treatment arm. | ||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||
| b Based on the regimen containing Reyataz. | ||
| c Median time on therapy. | ||
| d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. | ||
| Digestive System | ||
| Nausea | 4% | 8% |
| Jaundice/scleral icterus | 5% | * |
| Diarrhea | 2% | 12% |
| Skin and Appendages | ||
| Rash | 3% | 2% |
| Study AI424-034 | Studies AI424-007, -008 | |||
|---|---|---|---|---|
| 64 weeksc Reyataz 400 mg once daily + lamivudine + zidovudinee | 64 weeksc efavirenz 600 mg once daily + lamivudine + zidovudinee | 120 weeksc,d Reyataz 400 mg once daily + stavudine + lamivudine or didanosine | 73 weeksc,d nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or didanosine | |
| (n=404) | (n=401) | (n=279) | (n=191) | |
| * None reported in this treatment arm. | ||||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||||
| b Based on regimens containing Reyataz. | ||||
| c Median time on therapy. | ||||
| d Includes long-term follow-up. | ||||
| e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | ||||
| Body as a Whole | ||||
| Headache | 6% | 6% | 1% | 2% |
| Digestive System | ||||
| Nausea | 14% | 12% | 6% | 4% |
| Jaundice/scleral icterus | 7% | * | 7% | * |
| Vomiting | 4% | 7% | 3% | 3% |
| Abdominal pain | 4% | 4% | 4% | 2% |
| Diarrhea | 1% | 2% | 3% | 16% |
| Nervous System | ||||
| Insomnia | 3% | 3% | <1% | * |
| Dizziness | 2% | 7% | <1% | * |
| Peripheral neurologic symptoms | <1% | 1% | 4% | 3% |
| Skin and Appendages | ||||
| Rash | 7% | 10% | 5% | 1% |
Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients
The safety profile of Reyataz in treatment-experienced adults is based on 119 HIV-1 infected patients in clinical trials.
The most common adverse reactions are jaundice/scleral icterus and myalgia.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-experienced patients receiving Reyataz/ritonavir are presented in Table 6.
| 48 weeksc Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI | 48 weeksc lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI | |
|---|---|---|
| (n=119) | (n=118) | |
| * None reported in this treatment arm. | ||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||
| b Based on the regimen containing Reyataz. | ||
| c Median time on therapy. | ||
| d As a fixed-dose combination. | ||
| Body as a Whole | ||
| Fever | 2% | * |
| Digestive System | ||
| Jaundice/scleral icterus | 9% | * |
| Diarrhea | 3% | 11% |
| Nausea | 3% | 2% |
| Nervous System | ||
| Depression | 2% | <1% |
| Musculoskeletal System | ||
| Myalgia | 4% | * |
Laboratory Abnormalities in Treatment-Naive Patients
The percentages of adult treatment-naive patients treated with combination therapy including Reyataz (atazanavir sulfate) 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) with Grade 3–4 laboratory abnormalities are presented in Tables 7 and 8, respectively.
| a Based on the regimen containing Reyataz. | |||
| b Median time on therapy. | |||
| c ULN = upper limit of normal. | |||
| d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. | |||
| Variable | Limitc | 96 weeksb | 96 weeksb |
| Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined | lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined | ||
| (n=441) | (n=437) | ||
| Chemistry | High | ||
| SGOT/AST | ≥5.1 x ULN | 3% | 1% |
| SGPT/ALT | ≥5.1 x ULN | 3% | 2% |
| Total Bilirubin | ≥2.6 x ULN | 44% | <1% |
| Lipase | ≥2.1 x ULN | 2% | 2% |
| Creatine Kinase | ≥5.1 x ULN | 8% | 7% |
| Total Cholesterol | ≥240 mg/dL | 11% | 25% |
| Hematology | Low | ||
| Neutrophils | <750 cells/mm3 | 5% | 2% |
| Variable | Limitd | Study AI424-034 | Studies AI424-007, -008 | ||
|---|---|---|---|---|---|
| 64 weeksb | 64 weeksb | 120 weeksb,c | 73 weeksb,c | ||
| Reyataz 400 mg once daily + lamivudine + zidovudinee | efavirenz 600 mg once daily + lamivudine + zidovudinee | Reyataz 400 mg once daily + stavudine + lamivudine or + stavudine + didanosine | nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine | ||
| (n=404) | (n=401) | (n=279) | (n=191) | ||
| * None reported in this treatment arm. | |||||
| a Based on regimen(s) containing Reyataz. | |||||
| b Median time on therapy. | |||||
| c Includes long-term follow-up. | |||||
| d ULN = upper limit of normal. | |||||
| e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | |||||
| Chemistry | High | ||||
| SGOT/AST | ≥5.1 x ULN | 2% | 2% | 7% | 5% |
| SGPT/ALT | ≥5.1 x ULN | 4% | 3% | 9% | 7% |
| Total Bilirubin | ≥2.6 x ULN | 35% | <1% | 47% | 3% |
| Amylase | ≥2.1 x ULN | * | * | 14% | 10% |
| Lipase | ≥2.1 x ULN | <1% | 1% | 4% | 5% |
Dettolsept may be available in the countries listed below.
Chloroxylenol is reported as an ingredient of Dettolsept in the following countries:
International Drug Name Search
See also: Generic Diprolene
Diprolene AF is a brand name of betamethasone topical, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Diprolene AF:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Diprolene AF. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Diprolene AF.
Fluoxetine Biochemie may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetine Biochemie in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Dichlorophen is reported as an ingredient of Trivermicide Worm Capsules in the following countries:
Toluene is reported as an ingredient of Trivermicide Worm Capsules in the following countries:
International Drug Name Search
Selegiline-Chinoin may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Selegiline-Chinoin in the following countries:
International Drug Name Search
There are currently no drugs listed for "Erosive Gastritis".
Definition of Erosive Gastritis:
A form of severe inflammation of the stomach that can result in erosions in the lining of the stomach.
Complications include perforation, penetration
Medical Encyclopedia:
Promoxil may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Promoxil in the following countries:
International Drug Name Search
