TRIOMUNE 40 TabletsEach tablet contains:
Lamivudine …. 150 mgNevirapine ….. 200 mgStavudine ……. 40 mg
Triomune 40 Tablets are a combination of three drugs commonly used in the management of the human immunodeficiency virus (HIV-1) infection. Both stavudine and lamivudine belong to the nucleoside analog class of antiretroviral drugs. Both drugs act by terminating the growth of the DNA chain and inhibiting the reverse transcriptase of HIV-1. Nevirapine is a non-nucleoside reverse transcriptase inhibitor. It acts by directly inhibiting reverse transcriptase.
Each tablet of Triomune 40 contains half of the commonly prescribed daily doses of lamivudine, nevirapine and stavudine. All three drugs are to be administered twice daily, permitting a fixed-dose combination to be formulated. With the availability of this combination formulation, patients may be better able to adhere to triple drug regimens, thereby enhancing compliance.
What is Triomune?
Lamivudine is an antiviral medicine that prevents human immunodeficiency virus (HIV) or hepatitis B virus cells from multiplying in your body. Epivir is for treating HIV, which causes the acquired immunodeficiency syndrome (AIDS). Epivir is not a cure for HIV or AIDS. Epivir-HBV is for treating hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV. Lamivudine may also be used for purposes not listed in this medication guide. Nevirapine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Nevirapine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Nevirapine will not prevent or cure HIV or AIDS. Nevirapine may also be used for purposes not listed in this medication guide. Stavudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Stavudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Stavudine is not a cure for HIV or AIDS. Stavudine may also be used for purposes not listed in this medication guide.
Triomune 40 Tablets are indicated for the treatment of HIV-1 infection, once patients have been stabilized on the maintenance regimen of nevirapine 200 mg b.i.d. and have demonstrated adequate tolerability to nevirapine.
Additional important information regarding the use of nevirapine for the treatment of HIV-1 infection:
- Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Triomune 40 Tabletsshould not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk
- The 14-day lead-in period with nevirapine 200 mg daily dosing must be strictly followed, it has been demonstrated to reduce the frequency of rash
- If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.
Dosage and Administration
TRIOMUNE 40 Tablets : For patients weighing less than 60 kg TRIOMUNE 40: 1 tablet twice daily
Triomune 40 Tablets should not be administered to patients who have just initiated therapy with nevirapine. This is because an initial lead-in dosing of 200 mg nevirapine once daily for 2 weeks is recommended. Following this lead-in dose, a dose escalation (maintenance dose) to 200 mg nevirapine b.i.d. may be carried out in the absence of any hypersensitivity reactions (e.g., rash, liver function test abnormalities;
Monitoring of Patients
Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at twoweeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment . In some cases, hepatic injury has progressed despite discontinuation of treatment.
Triomune 40 Tablets are contraindicated in patients with clinically significant hypersensitivity to any of the components contained in the formulation.
Triomune 40 Tablets are contraindicated in patients with moderate or severe (Childs- Pugh Class B or C, respectively) hepatic impairment
Triomune 40 Tablets are also contraindicated in patients who are just initiating therapy with nevirapine. These patients require a lead-in dose of nevirapine 200 mg o.d. whereas this formulation contains the maintenance dose of nevirapine 200 mg b.i.d.
Nevirapine is contraindicated for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens.
There is no known antidote for lamivudine. One case of an adult ingesting 6 g of lamivudine was reported; there were no clinical signs or symptoms noted and hematologic tests remained normal. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required.
There is no known antidote for nevirapine overdosage. Cases of nevirapine overdose at doses ranging from 800 to 1800 mg/day for up to 15 days have been reported. Patients have experienced adverse events, including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. All events subsided following the discontinuation of nevirapine.
Experience with adults treated with 12 to 24 times the recommended daily dosage revealed no acute toxicity. Complications of chronicoverdosage include peripheral neuropathy and hepatic toxicity. Stavudine can be removed by hemodialysis; the mean ± SD hemodialysis clearance of stavudine is 120 ± 18 ml/min. Whether stavudine is eliminated by peritoneal dialysis has not been studied.
|Manufacturer||Cipla Pharma, India|
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