Zerit (stavudine)

How does it work?

Zerit capsules and oral solution contain the active ingredient stavudine (also known as d4T), which is a type of medicine called a nucleoside reverse transcriptase inhibitor. It is used in the treatment of HIV (human immunodeficiency virus) infection.

AIDS (acquired immune deficiency syndrome) is caused by infection with HIV. This virus invades cells of the immune system, particularly the white blood cells known as CD4 T-helper lymphocytes. These cells normally work to activate other cells in the immune system to fight infection. Since HIV kills CD4 T-helper cells, over time the body becomes less able to fight the virus or subsequent infections.

Once the virus is inside the CD4 T-cell it multiplies. Part of the process of viral multiplication involves the conversion of the virus genetic material, RNA, into DNA. This is achieved by a compound essential to the virus, called reverse transcriptase. Reverse transcriptase is a compound known as an enzyme. Stavudine works by blocking the action of this enzyme, thereby interfering with the conversion of viral RNA into DNA. This stops the virus from multiplying.

There is no cure for HIV, but stavudine is one of a number of medications that lowers the amount of virus in the body (viral load) and slows the progression of the disease from HIV to AIDS. Stavudine is used in conjunction with other anti-HIV drugs that attack the HIV virus in different ways. This helps prevent the virus becoming resistant to the medicine.

What is it used for?

HIV infection.

Warning!

This medicine should ideally be taken an hour before food on an empty stomach, but if this is not possible it can be taken with a light meal.

Zerit powder for oral solution requires reconstituting with water to make the solution. Your pharmacist will usually do this for you, but if they do not, carefully follow the instructions provided with the medicine. The reconstituted solution should be kept refrigerated at 2-8°C. Make sure it is out of the reach of children. Shake the bottle well before measuring each dose of the solution.

The HIV virus is very good at becoming resistant to anti-HIV medicines. For this reason it is very important that you carefully follow your doctor's instructions for taking your anti-HIV medicines, in order to maintain effective levels of the medicines in your blood. If the blood levels drop, the virus will be given more chance to replicate and develop resistance to the drugs. Skipping even a few doses increases the risk of treatment failure, so you should try to ensure that you take all your doses at the correct time, and that you visit your doctor for repeat prescriptions before you run out.

Treatment of HIV infection with anti-HIV medicines such as this one does not reduce the risk of transmitting the virus to other people through sexual contact or blood contamination. You should continue to use condoms to prevent transmitting the virus to your sexual partner.

Combination antiretroviral therapy has been associated with a redistribution of body fat (lipodystrophy) in people with HIV. The long-term consequences of this are currently unknown, however your doctor may wish to monitor your body fat, and the levels of lipids (eg cholesterol) and sugar (glucose) in your blood, and may prescribe additional medicines for any lipid disorders that occur during treatment with this medicine. Contact your doctor if you notice any changes in your body fat during treatment with your HIV medicines.

Some people being treated with combination antiretroviral therapy may develop a bone condition called osteonecrosis. This condition is caused by loss of blood supply to a bone, causing death of the bone tissue. The risk of the condition is thought to be increased by corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, advanced HIV disease and long-term use of antiretroviral medicines. If you notice any joint stiffness, aches and pains (especially of the hip, knee and shoulder) or difficulty in movement while using this medicine, you should tell your doctor so this can be investigated.

You should have regular blood tests to monitor your liver function while you are taking this medicine. This is especially important if you already have any problems with your liver, in particular chronic hepatitis B or C. Symptoms that may suggest a liver problem include persistent nausea and vomiting, abdominal pain, or the development of jaundice (a yellow colouring to the skin and the whites of the eyes). Consult your doctor if you experience any of these symptoms.

Consult your doctor immediately if you experience abnormal sensations in your feet and/or hands while taking this medicine, for example, numbness, tingling or burning sensations or pain, as this could be indicative of a nerve problem called peripheral neuropathy.

The class of medicines that stavudine belongs to can cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood, together with an enlarged liver. This side effect is more likely to occur in overweight women and people with liver disease (particularly hepatitis C treated with alpha interferon and ribavirin). If it occurs, lactic acidosis usually develops after a few months of treatment. Your doctor will monitor you for this side effect, but symptoms that might indicate it's development include rapid and/or deep breathing and non-specific symptoms such as feeling weak, sick or generally unwell, vomiting, abdominal pain, loss of appetite or weight loss. You should tell your doctor if you experience any of these.

People with diabetes should be aware that Zerit solution contains sucrose. Seek further advice from your doctor or pharmacist.

The use of this medicine has not been studied in people over 65 years of age.

Use with caution in

Decreased kidney function

Decreased liver function

Liver disease

Enlarged liver (hepatomegaly)

People with raised liver enzymes

Hepatitis, especially chronic hepatitis B or C

History of alcohol abuse

Obese women

History of pancreatitis

History of persistent numbness, tingling or pain in the hands and/or feet, caused by a disorder of the nerves (peripheral neuropathy).

Not to be used in

Known sensitivity or allergy to any ingredient.

Zerit capsules contain lactose and so should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Zerit capsules are not recommended for children under three months of age. Zerit oral solution should be used for this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine may be harmful to a developing foetus. It should not normally be given to pregnant women unless the potential benefits outweigh the potential risks to the foetus. Seek medical advice from your doctor.

It is recommended that women infected with the HIV virus must not breastfeed their infants under any circumstances, in order to avoid transmission of the virus to the baby. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain

Fatigue

Headache

Difficulty in sleeping (insomnia)

Abnormal dreams

Abnormal thinking

Dizziness

Pins and needles sensations

Disorder of the peripheral nerves causing weakness and numbness (peripheral neuropathy)

Depression

Rash or itching

Anxiety

Pain in the muscles and joints

Weakness or loss of strength (asthenia)

Loss of appetite

Elevated levels of lactic acid in the blood (lactic acidosis)

Liver disorders

Inflammation of the pancreas (pancreatitis)

Abnormal enlargement of breasts in men (gynaecomastia)

High blood glucose level (hyperglycaemia)

Raised cholesterol levels

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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