Stocrin

Stocrin - Precautions | Dosage | Side effects

Stocrin contains the active substance called efavirenz and belongs to the group of non-nucleoside reverse transcriptase inhibitors. It is used mostly in combination with other antiretroviral drugs for the treatment of HIV infection.

Precautions

Stocrin should not be used in patients who have history of hypersensitivity reactions to efavirenz (e.g. Stevens-Johnson syndrome, swelling of the face, tongue or throat, as well as erythema multiforme).

Patients who have severe liver damage should avoid taking this medicine. Monitoring of liver enzymes (AST and ALT) is recommended before and regularly during the therapy, including patients who don't have history of liver problems. Cases of liver failure were also reported in patients who had a completely healthy liver at the beginning of therapy.

Patients who have convulsions must use this medicine very cautiously, because seizures associated with the use of this drug have been reported in clinical trilas.

An increase in total cholesterol and triglyceride blood levels has also been reported, so periodic monitoring of LDL, VLDL, HDL and triglyceride levels is recommended while using this medicine.

Psychiatric side effects occur relatively often, including:

  • Severe depression
  • Suicidal ideas
  • Suicide attempts
  • Manic episodes
  • Paranoid reactions
  • Aggressive behavior

Patients and their families should be advised to immediately call a doctor if any of abovementioned side effects occur.

Side effects that affect the nervous system are also very common (affect 53% of patients), including:

  • Dizziness (28.3%)
  • Insomnia (16.3%)
  • Drowsiness and loss of interest (7%)
  • Abnormal dreams (6.2%)
  • Hallucinations (1.2%)

If you notice any of abovementioned symptoms, you should call your doctor.

Use of Stocrin simultaneously with the following drugs is contraindicated:

  • Bepridil - a medicine used to treat angina pectoris. Concomitant use with this medicine increases the risk of arrhythmias.
  • Ergot alkaloids (e.g. ergotamine and dihydroergotamine) used to treat migraine. Stocrin can significantly increase the concentration of these drugs in the blood which can lead to severe vasoconstriction and high blood pressure.
  • Antihistamines of newer generation (terfenadine and astemizole).
  • Pimozide (a medicine used to treat motor tics or uncontrolled movements). Concomitant use with this medicine may cause arrhythmias.
  • Benzodiazepines (e.g. triazolam and midazolam). Concomitant use with these medicines increases the risk of somnolence and shortness of breath.

Stocrin, pregnancy and breastfeeding

US FDA classified this drug into pregnancy category D because this drug may harm fetus. Pregnancy should be avoided while taking this medicine. It is advised to use appropriate contraceptive methods during three months after you discontinue Stocrin because the active substance (efavirenz) has long half-life, which means it will stay in your body for months.

Discontinue breastfeeding while taking this medicine.

Dosage

Stocrin tablets should be taken 2 hours after meals, before bedtime. The usual dose for adult patients is 600 mg once daily. Taking a tablet in the evening, reduces the incidence of side effects.

Stocrin is mainly used in combination with other drugs.

In children who weigh more than 40 kg (88 lbs.), the recommended dose is 600 mg once daily.

In children who weigh 32.5 - 40 kg (71 - 88 lbs.), the recommended dose is 400 mg once daily.

In children who weigh 25 - 32.5 kg (55 - 71 lbs.), the recommended dose is 350 mg once a day.

In children who weigh 20 - 25 kg (44 - 55 lbs.), the recommended dose is 300 mg once a day.

In children who weigh 15 - 20 kg (33 - 44 lbs.), the recommended dose is 250 mg once a day.

In children who weigh 13 - 15 kg (28 - 33 lbs.), the recommended dose is 200 mg once a day.

Interactions

Inform your doctor if you are taking any of the following medicines:

  • Protease inhibitors (drugs that are also used to treat HIV infection), such as: Dosage adjustment is required if Stocrin is administered concurrently with these drugs.
  • Atripla (a drug that contains three active substances, including efavirenz). These two drugs should not be administered concurrently as both contain efavirenz.
  • Antibiotics that are potent inhibitors of CYP3A4 enzymes, such as: clarithromycin and telithromycin. These drugs increase plasma levels of Stocrine, leading to an increased risk of side effects.
  • Antifungal drugs that are potent inhibitors of CYP3A4 enzymes, such as: fluconazole, itraconazole, voriconazole and posaconazole.
  • Carbamazepine (anticonvulsant). This medicine reduces the plasma levels of Stocrin, which reduces its effectiveness.
  • HMG CoA reductase inhibitors (statins), used to lower cholesterol, such as: atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and others. Stocrin reduces the concentration of these drugs in the blood, resulting in a decreased antihyperlipidemic effect.
  • Bupropion - a medicine used in the treatment of smoking cessation. Dose of bupropion needs to be adjusted.
  • Sertraline - a medicine used to treat depression and anxiety disorders. Sertraline dose adjustment is required.

Stocrin should not be used concomitantly with the St. John's Wort or grapefruit juice.

Side effects

Side effects of Stocrin include:

  • Unusual dreams
  • Drowsiness
  • Impaired concentration
  • Depressive symptoms
  • Convulsions
  • Hallucinations
  • Headache
  • Dizziness
  • Increased total cholesterol levels
  • Increased triglyceride levels
  • Suicidal thoughts and ideas
  • Aggression
  • Confusion
  • Hepatic insufficiency
  • Gynecomastia
  • Vertigo
  • Pancreatitis

References

  1. accessdata link
  2. PIL