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Daclaxen
Everest Pharmaceuticals Ltd.
Generic: Daclatasvir
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Daclaxen. Please consult your doctor.
CONSULT YOUR DOCTOR
Daclaxen may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
SAFE IF PRESCRIBED
Daclaxen is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
CONSULT YOUR DOCTOR
It is not known whether Daclaxen alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED
Daclaxen is safe to use in patients with kidney disease. No dose adjustment of Daclaxen is recommended.
SAFE IF PRESCRIBED
Daclaxen is safe to use in patients with liver disease. No dose adjustment of Daclaxen is recommended.
Medicine Overview of Daclaxen 60mg Tablet
Introduction
Daclaxen is an antiviral medication. It is used along with other medications for the treatment of chronic hepatitis C virus (HCV) infection. It works by lowering a load of hepatitis C virus in the body and removing the virus from the blood over a period of time. Daclaxen should be taken in the dose and duration as advised by your doctor. It should be taken with or without food, preferably at a fixed time. Do not skip any doses and finish the full course of treatment even if you feel better If you miss a dose, take it as soon...
... Show moreUses of Daclaxen
- Chronic hepatitis C virus (HCV) infection
Side effects of Daclaxen
Common
- Fatigue
- Headache
- Nausea
- Insomnia (difficulty in sleeping)
- Anemia (low number of red blood cells)
How to use Daclaxen
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Daclaxen may be taken with or without food, but it is better to take it at a fixed time.
How Daclaxen works
Daclaxen is an antiviral medication. It works by lowering a load of hepatitis C virus in the body and removing the virus from the blood over a period of time.
Quick Tips
- Daclaxen is used along with other medications for the treatment of chronic hepatitis C virus (HCV) infection.
- Do not skip any doses and finish the full course of treatment even if you feel better.
- It has fewer side effects compared to other similar medications.
- Take it with food, preferably at the same time everyday.
- You will usually need to take this medicine every day for either 12 or 24 weeks.
- It may cause fatigue, dizziness, and blurred vision. Don't drive or do anything requiring concentration until you know how it affects you.
- Your doctor may monitor your liver function and the amount of hepatitis C virus in your body regularly.
- Do not stop taking Daclaxen without your doctor’s advice.
Brief Description
Indication
Chronic hepatitis C virus infection in adults.
Administration
May be taken with or without food.
Adult Dose
Hepatitis C Indicated for use with sofosbuvir for chronic hepatitis C virus (HCV) genotypes 1 and 3 infection Genotype 1 Without cirrhosis or with compensated (Child-Pugh A) cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Decompensated (Child-Pugh B or C) cirrhosis or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks Genotype 3 Without cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis, or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks...
... Show moreRenal Dose
Renal impairment (any degree): No dose adjustment required
Contraindication
Hypersensitivity. Co-administration w/ strong CYP3A4 inducers & P-gp eg phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
Mode of Action
Inhibits NS5A, a nonstructural protein encoded by HCV.
Binds to the N-terminus within domain 1 of NS5A, which may cause structural distortions that interfere with NS5A functions, and thereby inhibits both viral RNA replication and virion assembly.
Precaution
Patients w/ genotype 1 infection & compensated cirrhosis; receiving amiodarone; decompensated liver disease; prior exposure to a NS5A inhibitor; pre-, peri- or post-liver transplant or other organ transplant; HIV/HCV, HBV co-infected patients.
Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn & adolescents <18 yr.
Lactation
Unknown if distributed in human breast milk
Side Effect
>10%
Headache (14%),Fatigue (14%)
1-10%
Nausea (8%),Diarrhea (5%),Elevated lipase, >3 x ULN (2%)
Pregnancy Category Note
Pregnancy
No data in pregnant women are available
If daclatasvir and sofosbuvir are administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen (see ribavirin prescribing information)
Lactation
Unknown if distributed in human breast milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interaction
May lead to lower exposure & loss of efficacy w/ phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone & St. John's wort. Decreased plasma levels & therapeutic effect w/ strong or moderate CYP3A4 & P-gp inducers. Increased plasma levels w/ strong CYP3A4 inhibitors. May increase systemic exposure of P-gp, OATP, 1B1, OCT1 or BCRP substrates. Boceprevir, telaprevir, atazanavir/ritonavir, efavirenz, cobicistat-containing, clarithromycin, telithromycin, erythromycin, dabigatran, etexilate, posaconazole, voriconazole, amiodarone, digoxin, Ca channel blockers, HMG-CoA reductase inhibitors.
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