绥美凯的说明书

Instructions

Generic name: Doptabalamid tablets

Product name: Suimeikai

All names: Trimeq, Docetabalamid, TRIUMEQ, Inbec

【Suimeikai Ingredients】

Suimeikai is a compound preparation, each tablet contains dolutegravir sodium (calculated as dolutegravir) 50 mg, abacavir sulfate (calculated as abacavir) 600 mg and lamivudine 300 mg.

【Suimeikai traits】

Suimeike is a film-coated tablet that appears white or off-white after the coating is removed.

【Indications】

It is suitable for the treatment of adults and adolescents over 12 years old (with a weight of at least 40kg) infected with human immunodeficiency virus (HIV).

[Usage and dosage of Suimeikai]

Suimeikai should be taken under the guidance of a physician with experience in HIV infection.

dose

Adults and teenagers (weighing at least 40kg)

For adults and adolescents, the recommended dose of Trimax is one tablet once daily.

Adults or adolescents whose body weight is less than 40 kg should not be given Trimax because Trimax is a fixed-dose tablet and the dose cannot be reduced.

Trimax is a fixed-dose tablet and should not be used in patients who require dose adjustments. If one of the active ingredients needs to be discontinued or a dose adjustment is required, separate formulations of dolutegravir, abacavir, or lamivudine may be used. In these cases, physicians should refer to the respective product information for these medicines.

Miss a dose

If the patient misses a dose of Suimei Kai and there are more than 4 hours before the next dose, Sui Meikai should be taken as soon as possible. If the next dose is less than 4 hours away, patients should not take the missed dose and simply resume their usual dosing schedule.

elderly patients

There are limited data on the use of dolutegravir, abacavir, and lamivudine in patients aged ≥65 years, and there is no evidence that older patients require different doses than younger adults. Taking into account age-related changes, such as decreased renal function and changes in hematological parameters, special caution is recommended when administering the drug in this age group.

kidney damage

Patients whose creatinine clearance rate is less than 50mL/min are not recommended to take Suimeikai.

liver damage

Abacavir is primarily metabolized by the liver. There are no clinical data in patients with moderate or severe hepatic impairment, therefore, use of Trimax is not recommended unless deemed necessary. For patients with mild hepatic impairment (Child-Pugh score 5-6), close monitoring is required, including monitoring of abacavir plasma levels if feasible.

children crowd

The safety and effectiveness of Suimeikan in children under 12 years of age have not been established. No data yet.

Dosing method

Oral

SuimeiKai can be taken with or without food.

【Adverse reactions】

Clinical data on Trimax are limited, and the most commonly reported adverse reactions that are possibly or probably related to dolutegravir and abacalongvir/lamivudine are nausea (12%), insomnia (7%), dizziness (6%), and headache (6%).

Adverse reactions (nausea, vomiting, diarrhea, pyrexia, drowsiness, rash) occur frequently in patients with abacavir hypersensitivity reactions. Therefore, patients who develop these symptoms should be carefully evaluated for the presence of this hypersensitivity reaction. Very rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported and abacavir hypersensitivity cannot be excluded. In such cases, abacavir-containing medicinal products should be discontinued.

In individual patients, the most serious adverse events that may be associated with dolutegravir and abacavir/lamivudine are hypersensitivity reactions, including rash and severe hepatic effects.

An analysis of pooled data from Phase IIb to IIIb clinical trials found that the adverse reactions observed with the combination of dolutegravir + abacavir/lamivudine were generally consistent with the adverse reaction profiles of the single ingredients dolutegravir, abacavir, and lamivudine.

There was no difference in the severity of adverse reactions observed between the combination and the single ingredients.

【Taboo】

Contraindicated in patients with known hypersensitivity to dolutegravir, abacavir, and lamivudine or any excipients.

Concomitant use with dofetilide and pisicanide is prohibited.