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Hepatitis c Medication (Sofosbuvir and Daclatasvir)
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Mr. Simranjit Singh Gandhi
Call: Whatsup/Viber = +91-9811604444
Web: http://gandhimedicos.com/product/ribasure-buy-ribasure-capsules-online-ribasure-200mg-price-buy-ribavirin-200mg-online-ribavirin-200mg-price/
RIBAVIRIN IS BACK
AVAILABLE NOW.........................

RIBASURE (Ribavirin 200mg Capsules)
COMPOSITION:
Each Hard Gelatin Capsule Contains:
Ribavirin USP ………. 200 mg
PHARMACOLOGICAL CLASSIFICATION:
Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
PHARMACOLOGICAL ACTION:
Mechanism of action:
Ribavirin (RIBASURE) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses. The mechanism by which RIBASURE in combination with other medicinal products exerts its effects against HCV is unknown.
Pharmacodynamics:
Antiviral Activity in Cell Culture
The antiviral activity of Ribavirin in the HCV-replicon is not well understood and has not been defined because of the cellular toxicity of Ribavirin.
Resistance HCV genotypes show wide variability in their response to pegylated recombinant human interferon/ribavirin therapy. Genetic changes associated with the variable response have not been identified.
Cross-resistance
There is no reported cross-resistance between pegylated/non-pegylated interferons and Ribavirin.
Pharmacokinetics:
Absorption
Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively). Absorption is extensive with approximately 10 % of a radiolabelled dose excreted in the faeces. However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Distribution
Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Biotransformation
Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite. Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Elimination
Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose to single-dose AUC12hr.
Special populations:
Renal Dysfunction
The pharmacokinetics of ribavirin were assessed after administration of a single oral dose (400 mg) of ribavirin to non HCV-infected subjects with varying degrees of renal dysfunction.
The multiple-dose pharmacokinetics of ribavirin cannot be accurately predicted in patients with renal dysfunction. Ribavirin is not effectively removed by hemodialysis.
Hepatic Dysfunction
The effect of hepatic dysfunction was assessed after a single oral dose of ribavirin (600 mg). \
Elderly Patients
Pharmacokinetic evaluations in elderly subjects have not been performed.
Gender
There were no clinically significant pharmacokinetic differences noted in a single-dose trial of 18 male and 18 female subjects.
Pediatric Patients
The pharmacokinetics of RIBASURE (dose-normalized) is similar in adults and pediatric subjects.
INDICATIONS:
Chronic Hepatitis C (CHC) RIBASURE (ribavirin) in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease.
No safety and efficacy data are available for treatment of longer than one year.
CONTRA-INDICATIONS:
RIBASURE combination therapy is contraindicated in:
Women who are pregnant. RIBASURE may cause fetal harm when administered to a pregnant woman. RIBASURE is contraindicated in women who are or may become pregnant. If
Patients with autoimmune hepatitis.
Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cellanemia)
Patients with creatinine clearance less than 50 mL/min.
Co-administration of RIBASURE and didanosine is contraindicated because exposure to the active metabolite of didanosine (dideoxyadenosine 5′-triphosphate) is increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving didanosine in combination with ribavirin.
WARNINGS:
Inhalation Use in patients requiring mechanical ventilation should only be undertaken by health care providers and staff familiar with this mode of administration and the ventilator being used.
Contraindicated in women who are pregnant and in the male partners of women who are pregnant. Instruct patients to avoid pregnancy and to use at least 2 reliable forms of effective contraception during therapy and for 6 months after completion of treatment.
Monitor Prior to starting therapy, screen women of childbearing potential for pregnancy and obtain baseline laboratory and hematologic values.
Children
Capsule/Oral solution Safety and efficacy not established in treatment with RIBASURE or in children younger than 3 years.
Elderly Administer with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and comorbidity. Ribavirin inhalation is not indicated for use in adults.
Hypersensitivity Severe acute hypersensitivity reactions have been rarely observed.
Renal Function Adjust dose & do not use RIBASURE in patients with CrCl less than 50 mL/min.
Hepatic FunctionDiscontinue therapy in patients who develop hepatic decomposition during treatment.
Dental disorders
Dental and periodontal disorders have been reported.
Fatalities
Death during or shortly after treatment with aerosolized ribavirin has been reported.
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Mr. Simranjit Singh Gandhi
Whatsup/Viber:+91-9811604444
Web: http://gandhimedicos.com/product/tudofovir-buy-tudofovir-tablets-online-tenofovir-300mg-price-buy-tenofovir-300mg/
Available Now...........
TUDOFOVIR
(Tenofovir Disoproxil Fumarate Tablets IP)
COMPOSITION
Each film coated tablet contains:
Tenofovir Disoproxil Fumarate IP 300 mg
Colours : Indigo Carmine & Titanium Dioxide.
PHARMACOLOGY
Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine 5`-triphosphate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases alpha and beta, and mitochondrial DNA polymerase gamma.
PHARMACOKINETICS
The pharmacokinetics of tenofovir disoproxil fumarate has been evaluated in healthy volunteers and HIV-1 infected individuals. Tenofovir pharmacokinetics is similar between these populations.
Absorption: Tenofovir disoproxil fumarate is a water soluble diester prodrug of the active ingredient tenofovir. The oral bioavailability of tenofovir from tenofovir disoproxil fumarate in fasted patients is approximately 25%. Following oral administration of a single dose of tenofovir disoproxil fumarate 300 mg to HIV-1 infected patients in the fasted state, maximum serum concentrations (C max ) are achieved in 1.0 ± 0.4 hrs. C max and AUC values are 296 ± 90 ng/mL and 2287 ± 685 ng·hr/mL, respectively.
The pharmacokinetics of tenofovir are dose proportional over a tenofovir disoproxil fumarate dose range of 75 to 600 mg and are not affected by repeated dosing.
Effects of Food on Oral Absorption: Administration of tenofovir disoproxil fumarate following a high-fat meal (~700 to 1000 kcal containing 40 to 50% fat) increases the oral bioavailability, with an increase in tenofovir AUC of approximately 40% and an increase in C max of approximately 14%. However, administration of tenofovir disoproxil fumarate with a light meal did not have a significant effect on the pharmacokinetics of tenofovir when compared to fasted administration of the drug. Food delays the time to tenofovir C max by approximately 1 hour.
Distribution: In vitro binding of tenofovir to human plasma or serum proteins is less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 μg/mL. The volume of distribution at steady state is 1.3 ± 0.6 L/kg and 1.2 ± 0.4 L/kg, following intravenous administration of tenofovir 1.0 mg/kg and 3.0 mg/kg.
Metabolism and Elimination: In vitro studies indicate that neither tenofovir disoproxil nor tenofovir are substrates of CYP450 enzymes.
Following IV administration of tenofovir, approximately 70-80% of the dose is recovered in the urine as unchanged tenofovir within 72 hours of dosing. Following single dose, oral administration of tenofovir disoproxil fumarate, the terminal elimination half-life of tenofovir is approximately 17 hours. After multiple oral doses of tenofovir disoproxil fumarate 300 mg once daily (under fed conditions), 32 ± 10% of the administered dose is recovered in urine over 24 hours.
Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion.
INDICATIONS : TUDOFOVIR is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
DOSAGE AND ADMINISTRATION:
The dose of TUDOFOVIR is 300 mg once daily taken orally, without regard to food. Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Adults: The recommended dose for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Chronic hepatitis B: The optimal duration of treatment is unknown. Treatment discontinuation may be considered as follows:
– In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy. Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Paediatric patients: Tenofovir Disoproxil Fumarate Tablets is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy.
Elderly: No data are available on which to make a dose recommendation for patients over the age of 65 years.
Renal insufficiency: Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction. There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Dose interval adjustments are recommended for patients with creatinine clearance < 50 ml/min.
Mild renal impairment (creatinine clearance 50-80 ml/min): Limited data from clinical studies support once daily dosing of tenofovir disoproxil fumarate in patients with mild renal impairment.
Moderate renal impairment (creatinine clearance 30-49 ml/min): Administration of 245 mg tenofovir disoproxil (as fumarate) every 48 hours is recommended based on modelling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients: Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths; therefore use in this group of patients is not recommended. If no alternative treatment is available, prolonged dose intervals may be used as follows:
Severe renal impairment: 245 mg tenofovir disoproxil (as fumarate) may be administered every 72-96 hours (dosing twice a week).
Haemodialysis patients: 245 mg tenofovir disoproxil (as fumarate) may be administered every 7 days following completion of a haemodialysis session*.
These dose adjustments have not been confirmed in clinical studies. Simulations suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response. Therefore clinical response to treatment and renal function should be closely monitored.
*Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance < 10 ml/min.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
If it is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis.
CONTRAINDICATIONS:
TUDOFOVIR is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
PRECAUTIONS AND WARNING:
Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors.
Patients Co-infected with HIV and Hepatitis B Virus
It is recommended that all patients with HIV be tested for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy. It is not indicated for the treatment of chronic HBV infection and the safety and efficacy of tenofovir disoproxil fumarate have not been established in patients co-infected with HBV and HIV.
Renal Impairment Tenofovir is principally eliminated by the kidney. Dosing interval adjustment is recommended in all patients with creatinine clearance <50 mL/min. No safety data are available in patients with renal dysfunction who received tenofovir disoproxil fumarate using these dosing guidelines. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported in association with the use of tenofovir disoproxil fumarate.
Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent. Patients at risk for, or with a history of, renal dysfunction and patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus. It should not be used in combination with the fixed-dose combination product containing tenofovir disoproxil fumarate as one of its components.
Bone Effects
In both arms of the study 903 through 144 weeks, decreases from baseline in bone mineral density (BMD) were seen at the lumbar spine and hip. Changes in BMD at the hip were similar between the two treatment groups (-2.8% ± 3.5 in the tenofovir disoproxil fumarate group vs. -2.4% ± 4.5 in the stavudine group). In both groups, the majority of the reduction in BMD occurred in the first 24–48 weeks of the study and this reduction was sustained through Week 144.
SIDE EFFECTS:
HIV-1: Assessment of adverse reactions from clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil fumarate (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-natïve patients received treatment with tenofovir disoproxil 245 mg (as fumarate) (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
See also Post-marketing experience below.
Metabolism and nutrition disorders:
Very common: hypophosphataemia
Nervous system disorders:
Very common: dizziness
Gastrointestinal disorders:
Very common: diarrhoea, vomiting, nausea
Common: flatulence
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Hepatitis B: Assessment of adverse reactions from clinical study data is based on experience in two double-blind comparative controlled studies in which 641 patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg (as fumarate) daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency. Frequencies are defined as common (≥ 1/100, < 1/10). See also Post-marketing experience below.
Nervous system disorders:
Common: headache
Gastrointestinal disorders:
Common: diarrhoea, vomiting, abdominal pain, nausea, abdominal distension, flatulence
Hepatobiliary disorders:
Common: ALT increase
General disorders and administration site conditions:
Common: fatigue
Exacerbations during treatment: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil fumarate-treated patients versus 1.9% of adefovir dipivoxil-treated patients.
Post-marketing experience: In addition to adverse reaction reports from clinical studies the following possible adverse reactions have also been identified during post-marketing safety surveillance of tenofovir disoproxil fumarate. Frequencies are defined as rare (≥ 1/10,000, < 1/1,000) or very rare (< 1/10,000) including isolated reports. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot always be made.
Metabolism and nutrition disorders:
Rare: lactic acidosis
Not known: hypokalaemia
Respiratory, thoracic and mediastinal disorders:
Very rare: dyspnoea
Gastrointestinal disorders:
Rare: pancreatitis
Hepatobiliary disorders:
Rare: increased transaminases
Very rare: hepatitis
Not known: hepatic steatosis
Skin and subcutaneous tissue disorders:
Rare: rash
Musculoskeletal and connective tissue disorders:
Not known: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
Renal and urinary disorders:
Rare: acute renal failure, renal failure, proximal renal tubulopathy (including Fanconi syndrome), increased creatinine
Very rare: acute tubular necrosis
Not known: nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus
General disorders and administration site conditions:
Very rare: asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
DRUG INTERACTIONS
Interaction studies have only been performed in adults.
Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.
Concomitant use not recommended: Didanosine: Co-administration of tenofovir disoproxil fumarate and didanosine is not recommended Renally eliminated medicinal products: Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil fumarate with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, h OAT 3 or MRP 4 (e.g. cidofovir) may increase serum concentrations of tenofovir and/or the co-administered medicinal products.
Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product. Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2
Other interactions:
Interactions between tenofovir disoproxil fumarate and protease inhibitors and antiretroviral agents other than protease inhibitors Atazanavir/Ritonavir , Lopinavir/Ritonavir & Darunavir/Ritonavir
Studies conducted with other medicinal products: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
OVERDOSAGE
Limited clinical experience at doses higher than the therapeutic dose of tenofovir disoproxil fumarate 300 mg is available. In Study 901, 600 mg tenofovir disoproxil fumarate was administered to 8 patients orally for 28 days. No severe adverse reactions were reported. The effects of higher doses are not known.
If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
PACKING:
HDPE Bottle pack of 30 tablets and packed in a unit carton along with package insert.
SHELF LIFE: 24 months from the date of manufacturing
STORAGE INSTRUCTIONS:
Store below 30ºC. Protect from light.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original container.
Do not use this medicine after the expiry date which is stated on the bottle.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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