Ritoheet-L Tablets (Generic Lopinavir and Ritonavir Tablets)

Ritoheet-L Tablets (Generic Lopinavir and Ritonavir Tablets)

Uses of Ritoheet-L Tablets

Ritoheet-L tablets (Generic Lopinavir and Ritonavir tablets) is used with other medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.

Ritoheet-L tablets will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lopinavir and ritonavir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

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Tablets (Generic

and

Ritoheet-L Tablets Dosage

The recommended dosage of Ritoheet-L tablets (Generic Lopinavir and Ritonavir Tablets) is 800 mg/200 mg (4 tablets of Ritoheet-L 200 mg/50 mg) orally once a day, or 400 mg/100 mg (2 tablets of Ritoheet-L 200 mg/50 mg) Twice daily. The dose of Ritoheet-L tablets must be increased when administered in combination with Efavirenz, Nevirapine or Nelfinavir. In such cases the recommended dosage is 500 mg/125 mg (2 tablets of 200 mg/50 mg + 1 tablet of 100 mg/25 mg) twice daily. The recommended dosage of Ritoheet-L in pregnant patients with no documented Lopinavir-associated resistance substitutions is 400/100 mg of twice daily.

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Contraindications

Ritoheet-L tablets are contraindicated in persons with a hypersensitivity (allergy) (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to Lopinavir , Ritonavir or any of the other ingredients of this medicine. This medicine is also contraindicated in cases of Severe hepatic insufficiency.

Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated plasma levels may result in serious and/or lifethreatening events is contraindicated.

Co-administration with potent CYP3A inducers where significantly reduced Lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross resistance is also contraindicated.

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Ritoheet-L Tablets (Generic Lopinavir and Ritonavir Tablets)

Warnings

The following have been observed in patients receiving Ritoheet-L: The concomitant use of Ritoheet-L and certain other drugs may result in known or potentially significant drug interactions. Toxicity in preterm neonates: Lopinavir and Ritonavir oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. A safe and effective dose of Lopinavir and Ritonavir oral solution in this patient population has not been established. Pancreatitis: Fatalities have occurred; suspend therapy as clinically appropriate. Hepatotoxicity: Fatalities have occurred. Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations. III may be required.

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Warnings

QT interval prolongation and isolated cases of torsade de pointes have been reported although causality could not be established. Avoid use in patients with congenital long QT syndrome, those with hypokalemia, and with other drugs that prolong the QT interval.

PR interval prolongation may occur in some patients. Cases of second and third degree heart block have been reported. Use with caution in patients with pre-existing conduction system disease, ischemic heart disease, cardiomyopathy, underlying structural heart disease or when administering with other drugs that may prolong the PR interval. Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia, immune reconstitution syndrome,redistribution /accumulation of body fat.

Overdose

Human experience of acute overdosage with Lopinavir and Ritonavir tablets (Ritoheet-L) is limited. The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea /abnormal stool. The signs of toxicity observed in mice, rats or dogs included decreased activity, ataxia, emaciation, dehydration and tremors.

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Overdose

Treatment of overdose with Ritoheet-L should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

There is no specific antidote for overdose with Ritoheet-L. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage.

Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since Lopinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the drug.

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Tablets (Generic Lopinavir and

Ritoheet-L Tablets During Pregnancy

Lopinavir / Ritonavir tablets (Ritoheet-L tablets) is classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Ritoheet-L (Lopinavir and Ritonavir Tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No treatment-related malformations were observed when Lopinavir in combination with Ritonavir was administered to pregnant rats or rabbits. Embryonic and fetal developmental toxicities (early resorption, decreased fetal viability, decreased fetal body weight, increased incidence of skeletal variations and skeletal ossification delays) occurred in rats at a maternally toxic dosage.

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