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Heptavir

PRODUCT DETAILS

Trade name : Heptavir
Generic : Lamivudine
Strength availability : 150mg
Manufactured by : Hetero
Package : 10 x 10 Tablets
Category : Anti-retroviral agent

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Heptavir tablets are hostile to retroviral pharmaceutical, which containing a functioning substances like lamivudine. Heptavir is correlate with HIV-1infection treatment. Lamivudine is a prohibitor of reverse transcriptase enzyme, analogue of Zalcitabine. Lamivudine is artificially delegated nucleoside analogue, dynamic in both HIV-1 diseases and hepatitis B contamination conditions. Lamivudine are none relieving the contamination; however it ready to lessen the movement of HIV disease to AIDS.

INDICATION

The usual prescribing information of Heptavir is used to treat HIV-1 infections.

DOSAGE

The prescribed dose of Heptavir for adult in HIV-1 infection is 150mg given orally for twice a day or 300mg given orally for once a day in combination with other antiretroviral agents. The prescribed dose of Heptavir for adult in chronic Hepatitis B is 100mg given orally for once a day for the treatment of chronic HBV infection along with evidence of hepatitis B viral replication and active liver inflammation. In pediatric patients usual dose for HIV-1 infections administered as The patient weighing of 14 to < 20 given one tablet of 150mg as morning 75mg and evening 75mg. The patient weighing of ≥ 20 kg to 25 kg given 1 1/2 tablet of 225mg as administer morning 75mg and evening 150mg The patients weighing of ≥ 25kg given 2 tablets of 300mg as morning 150mg and evening 150mg. For chronic hepatitis B: max dose is 100mg/day 2 years or older administrate 3mg/kg orally once a day Heptavir tablets should be administered with or without food. Heptavir should not be chew, crush or broke. It should be administer with whole of water.

PHARMACOLOGY

Lamivudine is one of the active moieties present in Heptavir tablets. Lamivudine is chemically structured as nucleoside analogue. Lamivudine is phosphorylated into dynamic 5' triphosphate metabolite intracellularly (lamivudine triphosphate 3TC-TP. This dynamic metabolite includes in hindrance of switch transcriptase through chain end after addition of nucleotide simple.

PHARMACOKINETIC

Absorption: Lamivudine has better absorption capacity, which is highly absorbed after administration. The oral mean bioavailability of both lamivudine is 87% respectively.
Distribution: The human plasma protein binding nature of lamivudine is very low. The apparent volume of distribution of lamivudine is 1.3 plus or minus 0.4L/kg.
Metabolism :
The metabolism of lamivudine is highly metabolized to trans-sulfoxide and sulfotransferases is essential for biotransformation of lamivudine.
Excretion :
The systemic clearance value of lamivudine is 0.33 plus or minus of 0.06L/hr/kg. The renal clearance of lamivudine is 0.22 plus or minus to 0.06L/h/kg. The mean terminal half life period of Heptavir tablets are; Lamivudine: 5 to 7 hours

Occurrence of lamivudine resistance may happen

The potency of lamivudine for HIV/HBV co infected patients has not been evaluated. Rise of hepatitis B infection variations related with protection from lamivudine has additionally been accounted for in HIV-1-contaminated subjects who have gotten lamivudine-containing antiretroviral regimens within the sight of simultaneous disease with hepatitis B infection.
Hypersensitivity reactions :
The most serious adverse reactions occur during Heptavir therapy is hypersensitivity reactions. This severe effect is occurs due to presence of two nucleoside analogues in Heptavir. Major symptoms are; Diarrhea GI disorders Fever Rash Respiratory problems Patient who are having a gene called HLA-B*5701 allele should have greater extent for hypersensitivity effects due to abacavir. To avoid this condition, patient must be screened for HLA-B*5701 allele before initiating the treatment with Heptavir.
Aggravation of hepatitis B :
This is occurred in patients who are affected by HIV/HBV co infection. Monitor the patient’s hepatic functions very closely for preventing this fatal case. In severe condition, continue the anti-hepatitis drugs.
Renal & liver damage :
Patient with creatinine clearance <50ml/min, Heptavir should not be used. For severe liver damage, this medication should not be used.
Immune reconstitution syndrome :
If this fatal case occurs, discontinue the treatment.
Fat redistribution :
This may leads to obesity majorly occurred in women. To overcome the problem patient should be treated with alternative measures and in severe condition stop the treatment.
Myocardial infarction : Patient has any risk of CVS disorders should be examine before starting the treatment. In severe condition, stop the therapy.

DRUG INTERACTION

Heptavir tablets are concurrent use with ribavirin, Ganciclovir, interferon alfa or other drugs may elevate the hematological toxicity effect of zidovudine. Avoid this concomitant treatment. Drug that varies the blood concentration of lamivudine is; Lamivudine 150mg with Nelfinavir 750mg for three times a day leads to causes increasing AUC of lamivudine by 10%. Lamivudine 300mg with trimethaprim 160mg & Sulfamethoxazole 800mg causes increasing AUC of lamivudine by 43%. Ribavirin causes reduction of phosphorylation of lamivudine.

CONTRAINDICATION

Heptavir tablets are contraindicated to; Patients who are having HLA-B*5701 Patients are having any hypersensitivity reactions to Heptavir Patients with moderate or severe liver damage

OVER DOSAGE

The over dosage of Heptavir is treated by; Providing supportive treatment for the patients Monitor the manifestation associated with over dosage of Heptavir tablets Lamivudine is removed by using hemodialysis process, because it has low protein binding effect.

MISSED DOSE

In case of missed dose, patient should be consult with medical practitioner and follow the instruction given by physician. The regular dosing schedule should be retained. The missed dose leads to over dosage condition.

SIDE EFFECTS

Lab abnormalities :
Anemia, Neutropenia, Hepatic function test abnormalities, Increasing CPK, Increased blood glucose, Increased triglycerides, Thrombocytopenia, Increased level of bilirubin, Increased level of amylase, lipase.
Common side effects :
Insomnia, Depression, Headache or migraine, Fatigue, Malaise, Dizziness, Vertigo, Nausea, Diarrhea, Rash, Pyrexia, Abdominal pain, Abnormal dreams, Anxiety.
Other effects :
Pancreatitis, Myocardial infarction, Stevens Johnson’s syndrome, Toxic epidermal necrolysis, Fat redistribution, Stomatitis, Weakness, Aplastic anemia, Lymphadenopathy, Splenomegaly, Lactic acidosis, hepatic steatosis, Rhabdomyolysis, Seizures, Wheezing, Alopecia, Erythema multiforme.

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