Drug Interaction:
Interacting drugs- summary
Lamivudine + Zidovudine- coadmin of lamividine with zidovudine resulted in an increase of 33% of zidovudine Cmax
Trimethoprim-Sulphamethox- coadmin resulted in an increase in lamividine AUC, a decrease in Sulphamethox oral clearance and a decrease in renal clearance
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
106. Lamivudine 20mg 01-04-08
+ Stavudine 5mg dispersible tablets
(Addl.stgth)
Same as approved
HIV infections
Approved by the FDA in November 17. 1995
U.S FDA APPROVED DRUGS DURING 2004
214. FDC of Lamuvudine 300mg (ER) + 15-07-2004
Zidovudine 600mg (ER) +
Nevirapine 400mg tablets
Anti-Aids
U.S FDA APPROVED DRUGS DURING 2006
79. Lamivudine 40mg + 12-07-2006
Stavudine 10mg dispersible tablet HIV infection
104. Lamivudine 20mg + 11-08-2006
Nevirapine 35mg +
Stavudine 5mg tablet Anti-HIV
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Lamivudine Anti-HIV 27-03-1998
2.Lamivudine 40mg + Nervirapine 70mg 28-01-2005
+ Stavudine 10mg in 5ml powder for
suspension
Anti-HIV
3.Lamivudine 20mg + Nevirapine 35mg 11-08-2006
+ Stavudine 5mg tablet
Anti-HIV
4.Lamivudine 20mg + Stavudine 5mg 01-04-2008
dispersible tablets (Addl.Stgth.)
Same as approved
5.Lamivudine 30mg + Zidovudine 60mg 23-02-2009
+Nervirapine 50mg Oral suspension
(Tablets for oral suspension)
For the treatment of HIV patients
6.Lamivudine 40mg + Stavudine 10mg 12-07-2006
Dispersible tablet
For HIV infection
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Combikit of 2 tablet of Lamivudine 150mg + 06-07-2005
Zidovudine 300mg each and
1 tablet of Egavirenz 600mg
For HIV infection in adults
2.Lamivudine 40mg + 04-08-2005
Stavudine 10mg per 5ml reconstituted solution
For HIV infection
3.Lamivudine 150mg + 06-08-2005
Stavudine 40mg+
Effarvirenz 600mg Combikit tablet
For the treatment of HIV infection in adults
4.Lamivudine 150mg + 06-08-2005
Zidovudine 300mg +
Efravirenz 600mg Combipack
For the treatment of HIV infection in adults
5.Lamivudine 150mg + 26-11-1999
Zidovudine 300mg tablets
For the treatment of HIV infection
6.Lamivudine 20mg + 08-11-2006
Neviramine 35mg
Stavudine 5mg tablet
Anti-HIV
7.Lamivudine 30mg/60mg + 14-06-2005
Stavudine 6mg/12mg +
Nrvirapine 50mg/100mg dispersable tablet
For pediatric patients with HIV infection
8.Lamivudine 30mg + 23-02-2009
Zidovudine 60mg+
Nevirapine 50mg Oral suspn Tablets for oral supn.
For the treatment of HIV patients
9.Lamivudine 40mg + 07-12-2006
Stavudine 10mg dispersable tablet
For HIV infection
10.Lamivudine 150mg + 03-10-2003
Zidovudine 300mg +
Abacavir as sulphate 300mg tablet
Alone or in combination with other antiretro viral agents
for treatment for HIV-1 infection
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Lamivudine HIV/AIDS Glaxo- Wellcome 17-11-2009
Adverse Reaction:
Headache, malaise and fatigue, Fever and chills, skin rashes, Nausea, diarrhea, anorexia, Abdominal pain abdominal cramps, Dyspepsia. Insomnia and sleep disorders.
Contra-Indications:
Hypersens to the drug
Special precautions:
Renal function impairment, pregnancy, lactation, children
Dosages/ Overdosage Etc:
Approved by the FDA in november 17. 1995
HIV infections
.
Other Information:
EVIDENCE BASED MEDICINE (MIMS April 2003)
Post-herpetic Neuralgia
Comparitive effectiveness of various interventions
Prevention of post-herpetic neuralgia
Beneficial
1. Oral antiviral agents such as acyclovir, famciclovir, valaciclovir, netivudine
2. Tricyclic antidepressants (amitriptyline)
Unknown effectiveness
1. Levodopa
2. Amantadine
3. Isoprinosine
4. Adenosine monophosphate
Unlikely to be beneficial
1. Topical antiviral agents (idoxurine) for relief of acute oain only
2. Cimetidine
Ineffective or harmful
1. Corticosteroids
Relieving established post-herpetic neuralgia
Beneficial
1. Tricyclic antidepressants (amitriptyline)
2. Oxycodone (opiod)
3. Gabapentin (anticonvulasant)
Unknown effectiveness
1. Capsaicin (topical counterirritant)
2. Topical lignocaine
Ineffective or harmful
1. Epidural morphine
2. Dextromethorphan
KEY POINTS
1. Daily acyclovir reduced the relative risk of of post-herpetic pain at six months by about 50 % compared with placebo
2. Famciclovir significantly reduced pain duration after acute herpes zoster.
3. Idoxuridine was associated with short term pain relief in acute herpes zoster but did not prevent post-herpetic neuralgia
4. Conflicting evidence on whether corticosteroids alone prevent post-herpetic neuralgia. Limited evidence that high dose steroids and antiviral agents combined may speed healing of acute zoster. No evidence that it reduces post-herpetic neuralgia
5. Amitriptyline started during the acute episode reduced prevalence of post-herpetic neuralgia at six months
6. Insufficient evidence on the effect of other drug tretment.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Lamivudine. Also tell your healthcare care professional if you are allergic to
any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Lamivudine has not been studied in pregnant women. Before taking this
medicine make sure that your doctor knows if you pregnant or become
pregnant.
3. Breast-feeding-
It is known whether Lamivudine passes into breast milk. Mothers who are taking
this medicine and who wish to breast feed should discuss this with their doctor.
4.Children-
Lamivudine can cause serious side effects. It is especially important that you
discuss with your childs doctor before use.
5.Older adults-
Lamivudine has not been studied specifically in older people. Therefore,
it may not be known whether they work exactly the same way they do in
younger adults, or if they cause different side effects or problems in older people.
6. Other medicines-
Tell your doctor if you are using any of the following or /other prescription or
non-prescription (Over-the counter) OTC medicine.
7. Other medical problems-
The presence of other medical problems may affect the use of Lamivudine.
Make sure you tell your doctor if you have any other medical problems
especially-
Kidney disease- patients with kidney disease may have increased chance
of side effects.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Lamivudine, deoxycytidine analogue with antiviral properties is phosphorylated by host cell kinases to a triphosphate moiety that is active against hepatitis B virus(HBV). Lamivudine (formerly known as 3TC) is a synthetic nucleoside analog with activity against H IV
Pharmacokinetics:
Lamivudine was rapidly absorbed after oral administration in HIV patients. Absolute bioavailability in 12 adult patients was 86% for the tablet and 87% for the oral soln.
Interaction with Food:
Lamivudine can be administered with or without food.
Pregnancy and lactation:
Pregnancy:
Use during pregnancy only when required
Lactation:
Instruct mothers to discontinue nursing while taking the drug.
