Abec L

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BRAND :  ABEC L PRICE :  60$ STRENGTH : ABACAVIR 600 MG+LAMIVUDINE 300 MG ACTIVE :  ABEC-L-ABACAVIR-600MG-LAMIVUDINE-300MG COMPANY NAME :  EMCURE TABLETS :  30 TABLETS read more

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Drug profile of Abec L

Abec L tablets are anti-retroviral medication, which containing an active substances like abacavir & lamivudine.

Abec L is involved in HIV-1infection treatment.

Lamivudine is a prohibitor of reverse transcriptase enzyme, analogue of Zalcitabine.

Lamivudine is chemically classified as nucleoside analogue, active in both HIV-1 infections & hepatitis B infection conditions.

Abacavir is a nucleoside analogue of HIV reverse transcriptase inhibitor, analogue of guanosine.

Due to presence of this analogue, the HIV viral load should be reduced and postpones or prevents the destruction of immune system.

Both abacavir & lamivudine are none curing the infection, but it able to reduce the progression of HIV infection to AIDS.

Abacavir is mostly used by combination with other anti-retroviral medications

Brand name: Abec L

Active substances: Lamivudine & Abacavir sulphate

Strength: 300mg & 600mg equivalent to abacavir

Pack: 30 tablets in a container

Mfg: Emcure pharmaceuticals

Classified as: Anti-retroviral drugs

 

Prescribing information of Abec L

The common prescribing information of Abec L is used to treat HIV-1 infections.

Mechanism of Abec L

Abacavir:

Abacavir is characterized as carboxylic synthetic nucleoside reverse transcriptase inhibitor, which is active against HIV infection.

Abacavir is phosphorylated into a functioning metabolite known as carbovir triphosphate (deoxyguanosine 5'triphosphate) dGTP

This dynamic metabolite forbids the activity of reverse transcriptase by contending with dGTP and embedded into viral DNA

The development of viral DNA gets influenced by inclusion of nucleotide which causes absence of OH particle.

For the development of 5' to 3' phosphodiester linkage, an OH atom is necessary. The formation of 3’ phosphodiester linkage is in charge of chain stretching which get inhibited.

Lamivudine:

Lamivudine is one of the active moieties present in Abec L 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.

Absorption

Both the component has better absorption capacity, which is highly absorbed after administration.

The oral mean bioavailability of both lamivudine & abacavir is occurs by 87% & 83% respectively.

Distribution

The human plasma protein binding nature of lamivudine is very low.

Abacavir is bounds to human plasma protein by almost 50%.

The apparent volume of distribution of abacavir is 0.86 plus or minus 0.15L/kg; lamivudine is 1.3 plus or minus 0.4L/kg.

Metabolism

The metabolism of abacavir is held by using alcohol dehydrogenase & glucuronyl transferase enzymes.

The metabolism of lamivudine is highly metabolized to trans-sulfoxide and sulfotransferases is essential for biotransformation of lamivudine.

Excretion

The systemic clearance value of abacavir is 0.80L/hr/kg plus or minus 0.24L/hr/kg & lamivudine is 0.33 plus or minus of 0.06L/hr/kg.

The renal clearance of abacavir is 0.007 plus or minus to 0.0008L/h/kg; lamivudine is 0.22 plus or minus to 0.06L/h/kg.

The mean terminal half life period of Abec L tablets are;

Abacavir: 1.45 plus or minus to 0.32 hours.

Lamivudine: 5 to 7 hours

When to take the Abec L

Abec L tablets should be administered with or without food.

Abec L should not be chew, crush or broke. It should be administer with whole of water.

Dosage regimens of Abec L

Before starting the treatment with Abec L tablets, patient should be concealing for HLA-B*5701 allele.

The prescribed dose of Abec L tablets is one tablet should be administered as a single dose.

Abec L tablets should be combined with other anti-retroviral drugs.

The dosage adjustment should not be recommended;

Abec L is a fixed dose combination, dosage adjustment should not be suggested in case of;

Patients having creatinine clearance <50ml/min

Patient with mild hepatic impairment condition

Abec L is contraindicated to the patients suffered with moderate or severe hepatic impairment.

Abec L caused side effects

Severe hypersensitivity or sometimes causes fatal related to abacavir

Insomnia

Depression

Headache or migraine

Fatigue

Malaise

Dizziness

Vertigo

Nausea

Diarrhea

Rash

Pyrexia

Abdominal pain

Abnormal dreams

Anxiety

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

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

Drug- drug interaction

The HIV infected patients who are receiving methadone continuance treatment, combined with 600mg of abacavir as two times a day, this concludes as increasing the oral clearance of methadone.

This adjustment won't bring about a methadone measurement alteration in the larger part of patients; be that as it may, an expanded methadone dosage might be required in few patients.

Drug that varies the blood concentration of abacavir is;

Ethanol 0.7g/kg with 600mg of abacavir causes increasing AUC of abacavir by 41%.

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.

Food drug interaction

There is some minor food drug interaction may occur, alcohol containing food items should not consume during Abec L treatment.

Severe hazard occurring during Abec L treatment is increasing lipid levels.

Common food which produce interactions;

  • Grape fruit & juice
  • Seville orange
  • Garlic
  • Vitamin E containing foods
  • Calcium
  • St John’s wort (an herbal product)

Possible contraindications

Abec L tablets are contraindicated to;

Patients who are having HLA-B*5701

Patients are having any hypersensitivity reactions to abacavir

Patients with moderate or severe liver damage

Safety measures

The most serious adverse reactions occur during Abec L therapy is hypersensitivity reactions.

This severe effect is occurs due to presence of two nucleoside analogues in Abec L.

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 Abec L.

Lactic acidosis, hepatic steatosis: These fatal cases are majorly occurred in patients receiving anti-retroviral treatment as monotherapy or in combinations.

Discontinue the treatment for reducing this kind of adverse.

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.

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.

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.

Renal & liver damage:

Patient with creatinine clearance <50ml/min, Abec L should not be used.

For severe liver damage, this medication should not be used.

Pregnancy and lactation

Pregnancy category C

Abec L should not be used in both pregnant & lactating women.

Exposure of postnatal transmission occurs

The potency of Abec L has not been evaluated in pediatric patients.

Caution should be taken while using Abec L in geriatric patients.

Storage and handling

Abec L tablet container should be stored at 25oC (77oF).

Keep the container away from moisture, heat & light

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.

Over dosage

The over dosage of Abec L is treated by;

Providing supportive treatment for the patients

Monitor the manifestation associated with over dosage of Abec L tablets

Lamivudine is removed by using hemodialysis process, because it has low protein binding effect.

The removal of abacavir content from the body by hemodialysis is not known because it has 5% protein binding effects.

 

 

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