Medication info
Kivexa Tablets

Kivexa Tablets

Prescription medicationTabletOral
Ingredient · strength
Abacavir Sulfate›702mg / 1 tabletLamivudine›300mg / 1 tablet
Manufacturer / importer
GSK Korea
Appearance
Orange rectangular film-coated tablets
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201104756 · Approved 2011.07.28 · Insurance code 650002840

Summary

Main use
Treatment of HIV infection in combination with other antiretroviral drugs
Who takes it
Adults · Children
Adult dose
This medicine should be prescribed by a physician experienced in the treatment of HIV infection and may be administered with or without food. This medicine is a fixed-dose tablet and should not be prescribed to patients who require dose adjustment. If dose adjustment or discontinuation of one of the ingredients is necessary, abacavir or lamivudine may be prescribed separately; in such cases, the physician should refer to the prescribing information for the individual products. Adults and adolescents: The recommended dose is 1 tablet once daily. Patients with renal impairment: This medicine is not recommended for patients with a creatinine clearance below 30ml/min, because the required dose adjustment cannot be made. Patients with hepatic impairment: Abacavir is primarily metabolized in the liver. Use should be avoided in patients with moderate or severe hepatic impairment because there are insufficient data to support a dose. If abacavir is administered to patients with mild hepatic impairment (Child-Pugh score 5-6), careful monitoring is required, including monitoring of abacavir plasma concentrations where possible.
Child dose
Pediatric patients weighing 25kg or more: The recommended dose is 1 tablet once daily. Pediatric patients weighing less than 25kg: This medicine should not be administered to pediatric patients weighing less than 25kg because it is a fixed-dose tablet that cannot be reduced.

Ingredients

Importer
GSK Korea

Efficacy & effects

Treatment of HIV infection in combination with other antiretroviral drugs

View approved original text

This medication helps treat HIV infection when used in combination with other antiretroviral drugs. Patients can expect to suppress the replication of the HIV virus and protect their immune function by taking this medication. Combination therapy plays a crucial role in reducing resistance to the virus and maximizing treatment effectiveness. Regular check-ups and adherence to medication during the treatment process are required. This medication effectively improves the treatment of HIV infection.

How to take

Adult dose

This medicine should be prescribed by a physician experienced in the treatment of HIV infection and may be administered with or without food. This medicine is a fixed-dose tablet and should not be prescribed to patients who require dose adjustment. If dose adjustment or discontinuation of one of the ingredients is necessary, abacavir or lamivudine may be prescribed separately; in such cases, the physician should refer to the prescribing information for the individual products. Adults and adolescents: The recommended dose is 1 tablet once daily. Patients with renal impairment: This medicine is not recommended for patients with a creatinine clearance below 30ml/min, because the required dose adjustment cannot be made. Patients with hepatic impairment: Abacavir is primarily metabolized in the liver. Use should be avoided in patients with moderate or severe hepatic impairment because there are insufficient data to support a dose. If abacavir is administered to patients with mild hepatic impairment (Child-Pugh score 5-6), careful monitoring is required, including monitoring of abacavir plasma concentrations where possible.

Child dose

Pediatric patients weighing 25kg or more: The recommended dose is 1 tablet once daily. Pediatric patients weighing less than 25kg: This medicine should not be administered to pediatric patients weighing less than 25kg because it is a fixed-dose tablet that cannot be reduced.

Precautions

This medication can cause hypersensitivity reactions, so if symptoms such as fever or rash occur, it should be discontinued immediately. The risk of hypersensitivity is particularly high in patients with certain genetic traits, so genetic testing should be considered before taking this medication. During treatment with this medication, patients should closely monitor for any symptoms of hypersensitivity and consult healthcare professionals immediately if suspected. Hypersensitivity can be life-threatening, so it is important to stop the medication without delay if symptoms occur. Additionally, this medication should not be administered to patients with severe liver and kidney function impairment, and it should be used cautiously in patients at risk of hepatic disease or lactic acidosis. The safety of this medication has not been established during pregnancy, so pregnant women should determine use after consultation with their doctors, and breastfeeding women should avoid nursing while taking this medication. Regular tests for liver function, blood counts, kidney function, etc., should be conducted during treatment to check for adverse reactions, and any abnormal symptoms should be reported to healthcare professionals immediately. Caution should be taken while driving or operating machinery during treatment, and potential interactions with alcohol or certain medications should be discussed with healthcare professionals regarding any concurrent medications. No specific symptoms are known for overdose; however, if suspected, it is important to visit a medical facility immediately for appropriate treatment. Finally, this medication should be stored out of reach of children, and it is safest not to transfer it into other containers.

Side effects

  • Allergic reactions
  • fever
  • rash
  • pneumonia
  • bronchitis
  • pharyngitis
  • gastroenteritis
  • nausea
  • vomiting
  • diarrhea
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  • abdominal pain
  • oral ulcers
  • cough
  • sore throat
  • adult respiratory distress syndrome
  • respiratory failure
  • headache
  • sensory abnormalities
  • lymphocytopenia
  • elevated liver function tests
  • liver failure
  • hepatitis
  • myalgia
  • rhabdomyolysis
  • arthralgia
  • elevated creatine phosphokinase
  • elevated creatinine
  • renal failure
  • alopecia
  • drowsiness
  • fatigue
  • lethargy
  • edema
  • lymphadenopathy
  • hypotension
  • conjunctivitis
  • anaphylactic reaction
  • neutropenia
  • anemia
  • thrombocytopenia
  • aplastic anemia
  • peripheral neuropathy
  • pancreatitis
  • elevated serum amylase levels
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • upper respiratory infection
  • syphilis
  • gastrointestinal disturbances
  • heartburn
  • dizziness
  • pruritus
  • osteoporosis
  • hypertension
  • rhinitis
  • runny nose
  • depression
  • tinea capitis
  • oral candidiasis
  • herpes zoster
  • tinea
  • soft tissue infection
  • urinary tract infection
  • tuberculosis
  • bronchitis
  • viral infections
  • tonsillitis
  • infection
  • otitis media
  • fungal infections
  • oral abscess
  • parasitic infections
  • herpes simplex
  • flu-like syndrome
  • cystitis
  • sinusitis
  • esophageal candidiasis
  • aspergillosis
  • urethritis
  • excessive sneezing
  • furunculosis
  • otitis externa
  • anal disorders
  • constipation
  • dyspepsia
  • gastritis
  • epigastric discomfort
  • gastroenteritis
  • atrophic gastritis
  • dry mouth
  • gastroesophageal reflux
  • enteritis
  • periodontitis
  • anal bleeding
  • tongue pain
  • bloody stools
  • hiccups
  • changes in bowel habits
  • abdominal discomfort
  • abdominal bloating
  • esophagitis
  • dysphagia
  • gastric ulcer
  • gum swelling
  • gum bleeding
  • gum pain
  • intussusception
  • exacerbation of hemorrhoids
  • leg cramps
  • spinal canal stenosis
  • seizures
  • feeling of heaviness in the head
  • unconsciousness
  • visual field loss
  • neuropathic pain
  • burning sensation
  • tremors
  • balance disorders
  • dizziness
  • folliculitis
  • seborrheic dermatitis
  • dermatitis
  • genital warts
  • acne
  • skin damage
  • skin disorders
  • psoriasis
  • hyperhidrosis
  • sweating
  • deformity
  • onychomycosis
  • eczema
  • otitis externa
  • skin erosion
  • skin discoloration
  • skin exfoliation
  • anal pruritus
  • erythema
  • osteoarthritis
  • ligament disorders
  • arthritis
  • rheumatoid arthritis
  • temporomandibular joint dysfunction
  • flank pain
  • bursitis
  • plantar fasciitis
  • hypokalemia
  • hyperlipidemia
  • diabetes
  • hypophosphatemia
  • weight loss
  • weight gain
  • hypomagnesemia
  • hypoalbuminemia
  • hypocalcemia
  • abnormal blood sugar levels
  • chest pain
  • lethargy
  • chest discomfort
  • immune system disorders
  • fatigue
  • allergy
  • chills
  • increased sputum
  • sputum disease
  • hemoptysis
  • visual impairment
  • keratitis
  • dry eye
  • retinal detachment
  • retinal disease
  • blepharitis
  • conjunctival injection
  • eye pain
  • uveitis
  • macular edema
  • elevated blood pressure
  • orthostatic hypotension
  • increased systolic blood pressure
  • depression accompanied by anxiety
  • dementia
  • hyperbilirubinemia
  • cholelithiasis
  • fatty liver
  • jaundice
  • ureteral stones
  • bladder stones
  • frequent urination
  • nocturia
  • urinary incontinence
  • reduced creatinine clearance
  • hematuria
  • tinnitus
  • feeling of fullness in the ear
  • orchitis
  • epididymitis
  • benign prostatic hyperplasia
  • prostatitis
  • adrenal insufficiency
  • gynecomastia
  • palpitations
  • unspecified deep vein thrombosis
  • cervicitis
  • malignant lymphoma
  • unstable angina
  • upper limb fractures
  • pelvic fractures
  • road traffic accidents
  • neurosyphilis
  • infectious granuloma
  • lower limb fractures
  • burns

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to store it at room temperature between 1 to 30 degrees Celsius and not in excessively cold or hot places.

Appearance and packaging

Appearance

Orange rectangular film-coated tablets

Package unit

30 tablets (10 tablets/PTP X 3)

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.