Consumer medicine information

Hydopa

Methyldopa

BRAND INFORMATION

Brand name

Hydopa

Active ingredient

Methyldopa

Schedule

What is in this leaflet

This leaflet answers some common questions about Hydopa.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Hydopa against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Hydopa is used for

Hydopa is used to lower high blood pressure, also called hypertension.

Everyone had blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure. Hydopa helps to lower your blood pressure.

Hydopa works by controlling impulses along certain nerve pathways and as a result, widens blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

There is no evidence that Hydopa is addictive.

Hydopa is available only with a doctor's prescription.

Before you take Hydopa

When you must not take it

Do not take Hydopa if you have an allergy to:

any medicine containing methyldopa (as sesquihydrate) (e.g. Aldomet)
any of the ingredients listed at the end of this leaflet.

Do not take Hydopa if you:

currently have liver disease (e.g. hepatitis or cirrhosis.
Have hepatitis, cirrhosis, or certain liver diseases.

Do not take Hydopa if you are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs are used to treat depression and Parkinson's disease. Some examples of MAOIs include phenelzine, tranylcypromine and selegiline.

Ask your doctor or pharmacist if you are not sure whether you are taking one of these MAOI medicines.

Do not take Hydopa if the expiry date printed on the pack has passed.

If you take this medicine after the expiry date, it may not work as well. Do not take Hydopa if the packaging shows signs of tampering or the tablets do not look quite right.

If you are not sure whether you should start taking Hydopa, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

Liver problems
Angina (chest pain)

Tell your doctor if you have or are suspected of having phaeochromocytoma (a rare tumour of the adrenal gland).

Tell your doctor if you are undergoing dialysis (a procedure used to remove waste products from the blood of a person with kidney failure).

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

Hydopa passes into breast milk. Your doctor will discuss the risks and benefits of taking Hydopa when breastfeeding.

Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell them before you start taking Hydopa.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Hydopa or may affect how well it works. These include:

other medicines used to treat high blood pressure
lithium, a medicine used to treat mood swings and some types of depression
iron supplements and multivitamins containing iron.

You may need different amounts of your medicine or you may need to take different medicines.

Do not take Hydopa if you are taking a MAOI (e.g. moclobemide, phenelzine and tranylcypromine) Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure of whether you are taking any of these medicines, check your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Hydopa.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Hydopa

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

The dose varies from person to person.

This depends on your condition and whether you are taking any other medicines.

Your doctor will tell you how many tablets you need to take each day and when to take them.

How to take it

Swallow the tablets whole with a glass of water.

When to take it

Take your medicine at about the same time each day, unless your doctor tells you otherwise.

If you are taking it twice a day, take the tablets at breakfast time and dinner time - that is about 12 hours apart.

If you are taking it three times a day, take the tablets about 8 hours apart. Taking it at the same time each day will have the best effect on your blood pressure. It will also help you remember when to take it.

Hydopa can be taken with or without food.

How long to take it

Keep taking Hydopa for as long as your doctor recommends. Hydopa helps control high blood pressure but does not cure it. To properly control your condition, Hydopa must be taken every day on a long-term basis.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Hydopa. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Hydopa, you may feel dizzy, lightheaded, drowsy or you may faint. You may also experience nausea (feeling sick), vomiting, constipation, diarrhoea, gas/wind in the bowel or develop a bloated stomach.

While you are using Hydopa

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Hydopa.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you need to have surgery that requires a general anaesthetic, tell your doctor or dentist that you are taking Hydopa. Your blood pressure may drop suddenly.

If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up. You may feel light-headed or dizzy when you begin to take Hydopa or if the dose is increased. This is because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from bed or sitting, will help your body get used to the change in position and blood pressure. The problem usually goes away after the first few days.

If you need to have any blood or urine tests, tell your doctor that you are taking Hydopa. Hydopa may interfere with the results of some blood and urine tests.

If you going to have a blood transfusion, tell your doctor you are taking Hydopa or have taken it in the past few months. Hydopa may interfere with the tests used to decide which blood group you receive.

If you develop a fever, tell your doctor. Your doctor may ask you to have blood tests to make sure that Hydopa is not affecting your liver or blood.

Make sure you drink enough water during exercise and hot weather when you are taking Hydopa, especially if you sweat a lot. If you do not drink enough water while taking it, you may faint or feel lightheaded or sick. This is because your body doesn't have enough fluid and your blood pressure is low. If you continue to feel unwell, tell your doctor.

Since Hydopa is meant to be taken regularly, keep a continuous supply of medicine so you don't run out, especially over weekends or on holidays.

Have your blood pressure checked regularly when your doctor says to make sure Hydopa is working.

Visit your doctor regularly so they can check on your progress. Your doctor may want to check your liver function and blood count, especially within the first 12 weeks of starting Hydopa.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not take Hydopa to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Hydopa affects you. This medicine may cause cause drowsiness, dizziness or lightheadedness in some people, especially after the first few doses, or if the dose is increased. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, symptoms such as dizziness, lightheadedness or fainting may be worse.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Dizziness, lightheadedness or fainting may occur when you begin to take Hydopa, or if the dose is increased. This happens especially when you get up quickly from a sitting or lying position.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. This problem usually goes away after the first few days.

If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Hydopa.

This medicine helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

dizziness, lightheadedness
drowsiness
headache
weakness

The above list includes the more common side effects of your medicine. They are usually mild and short-lived. These side effects may occur at the beginning of treatment or when the dose is increased.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

ongoing weakness
fever shortly after starting Hydopa, for example, within the first 3 months
yellowing of the eyes or skin (jaundice)
darker urine than normal due to liver problems
pale stools
swelling of the feet or lower legs
nightmares, feeling strange or depressed
signs of frequent or worrying infections such as fever, chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
signs of anaemia such as tiredness, looking pale together with being short of breath when exercising and tingling or numbness of the hands or feet
itchy skin rash or other skin problems
a slow heart beat or pulse
worsening of angina (chest pain).
larger breasts than normal, especially in men.

The above list includes serious side effects. You may need urgent medical attention. These side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Hydopa

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Hydopa or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Hydopa tablets are round and yellow, marked "MD" over "250" on one side and "G" on the reverse.

Each pack contains 100 tablets.

Ingredients

The active ingredient in Hydopa is methyldopa (as sesquihydrate). Each Hydopa tablet contains methyldopa (as sesquihydrate) equivalent to 250 mg of anhydrous methyldopa.

The tablets also contain the following inactive ingredients:

anhydrous citric acid
disodium edetate
ethylcellulose
sodium starch glycollate
guar gum
colloidal anhydrous silica
magnesium stearate
Opadry Yellow OY-8462 (includes colours 104, 110, 171).

Hydopa tablets contain galactose.

Supplier

Hydopa is supplied in Australia by:

Alphapharm Pty Ltd (A Viatris Company)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

This leaflet was prepared on
8 September 2021.

AUST R 69482

Hydopa_cmi\ Sep21/00

Published by MIMS October 2021

BRAND INFORMATION

Brand name

Hydopa

Active ingredient

Methyldopa

Schedule

1 Name of Medicine

Methyldopa (as sesquihydrate).

2 Qualitative and Quantitative Composition

Each tablet contains methyldopa (as sesquihydrate) equivalent to 250 mg of anhydrous methyldopa.

Excipients with known effect.

Hydopa also contains trace amounts of galactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Hydopa 250 mg tablets are yellow film-coated, marked MD 250 on one side, G on the reverse.

4 Clinical Particulars

4.1 Therapeutic Indications

Hypertension (mild, moderate to severe).

4.2 Dose and Method of Administration

General.

Methyldopa is primarily excreted by the kidneys. Therefore, patients with impaired renal function may respond to lower doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease; this may be avoided by smaller doses.
Cessation of methyldopa therapy is followed by return of hypertension, usually within 48 hours. This is not complicated by an overshoot of blood pressure.
Therapy with methyldopa may be commenced in most patients already on treatment with other antihypertensive agents.
Methyldopa may also be given concomitantly with hydrochlorothiazide or beta-blocking agents.
When methyldopa is administered to patients on other antihypertensives, dosage adjustments of these agents may be required to effect a smooth transition. Withdraw these antihypertensive agents gradually if required (see manufacturers' recommendations on discontinuing these drugs).
Following such previous antihypertensive therapy, the initial dose of methyldopa should be limited to not more than 500 mg per day and increased as required at intervals of not less than 2 days.

Adults.

The usual starting dose is 250 mg two or three times daily in the first 48 hours. The daily dosage may then be increased or reduced, preferably at intervals of not less than 2 days, until an adequate response is achieved. The maximum recommended daily dosage is 3 g.
When methyldopa 500 mg is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily.
Many patients experience sedation for two or three days when treatment with methyldopa is initiated, or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first.

Children.

Initial dosage is based on 10 mg/kg of bodyweight daily in two to four doses. The daily dosage is then increased, or decreased, until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3 g daily, whichever is less.

4.3 Contraindications

Hydopa is contraindicated in patients:
with active hepatic disease, such as acute hepatitis and active cirrhosis;
with hypersensitivity (including hepatic disorders associated with previous methyldopa therapy) to any component of this product (see Section 4.4 Special Warnings and Precautions for Use);
on therapy with monoamine oxidase (MAO) inhibitors;
with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma;
with porphyria.

4.4 Special Warnings and Precautions for Use

Anaemia.

Acquired haemolytic anaemia has occurred rarely in association with methyldopa therapy. Should clinical symptoms indicate the possibility of anaemia, haemoglobin and/or haematocrit determinations should be performed. If anaemia is present, appropriate laboratory studies should be done to determine if haemolysis is present. Evidence of haemolytic anaemia is an indication for cessation of methyldopa therapy. Discontinuation of methyldopa alone, or the initiation of adrenocortical steroids, usually results in a prompt remission of anaemia. Rarely, however, fatalities have occurred.

Coombs test.

Some patients on continued treatment with methyldopa develop a positive direct Coombs test. The incidence of positive Coombs test as reported by different investigators has averaged between 10 and 20 percent. A positive Coombs test rarely occurs in the first six months of therapy with methyldopa and if not encountered within 12 months, is unlikely to develop with continued administration. This phenomenon is also dose related with the lowest incidence occurring in patients receiving 1 g of methyldopa or less per day. Reversal of the positive Coombs test occurs within weeks to months after discontinuation of methyldopa.
Should the need for transfusion arise, prior knowledge of a positive Coombs reaction will aid in evaluation of the cross match. Patients with a positive Coombs test at the time of cross match may exhibit an incompatible minor cross match. When this occurs, an indirect Coombs test should be performed. If negative, transfusion with such blood which is otherwise compatible in the major cross match may be carried out. However, if positive, the advisability of transfusion with blood compatible in the major cross match should be determined by a haematologist or expert in transfusion problems.
Rarely, a reversible decrease in the white blood cell count with a primary effect on the granulocytes has been seen. The granulocyte count returned promptly to normal on cessation of methyldopa. Reversible thrombocytopenia has occurred rarely.

Fever and hepatic function.

Occasionally, fever has occurred within the initial three weeks of methyldopa treatment. In some cases, this fever has been associated with eosinophilia or abnormalities in one or more liver function tests. Jaundice, with or without fever, may also occur, with onset usually within 2 or 3 months of commencement of therapy. In some patients the findings are consistent with those of cholestasis. Rare cases of fatal hepatic necrosis have been reported. Liver biopsy, performed in several patients with liver dysfunction, showed a microscopic focal necrosis compatible with drug hypersensitivity. Periodic determination of hepatic function and a white cell and differential blood count should be performed at intervals during the initial 6 to 12 weeks of therapy, or whenever an unexplained fever may occur. If fever, abnormalities in liver function tests or jaundice appear, treatment with methyldopa should be ceased. If related to methyldopa, the temperature and abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Methyldopa should not be reinstituted in such patients. Caution should be exercised when methyldopa is used in patients with a history of previous liver disease or dysfunction.
Patients may require reduced doses of anaesthetics when on methyldopa. If hypotension does occur during anaesthesia, it can usually be controlled by vasopressors. The adrenergic receptors remain sensitive during treatment with methyldopa.
Hypertension may recur after dialysis as methyldopa is removed by this procedure.
Depression following methyldopa administration has been reported. Care should be taken to monitor for depression, especially in patients with a history of depression.

Use in renal impairment.

See Section 4.2 Dose and Method of Administration.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Methyldopa may interfere with the measurement of urinary uric acid by the phosphotungstate method, serum creatinine by the alkaline picrate method and SGOT by colorimetric method. Interference with spectrophotometric methods for SGOT analysis has not been reported.
Since methyldopa will cause fluorescence in urine samples at the same wavelengths as catecholamines, spuriously high concentrations of urinary catecholamines may be reported. This will interfere with the diagnosis of catecholamine secreting tumour such as phaeochromocytoma or paraganglioma.
It is important to recognise this phenomenon before a patient with a possible catecholamine secreting tumour is subjected to surgery. Methyldopa does not interfere with measurement of VMA (vanillylmandelic acid), by those methods which convert VMA to vanillin. Methyldopa is contraindicated for the treatment of patients with catecholamine secreting tumour such as phaeochromocytoma or paraganglioma.
Rarely, when urine is exposed to air after voiding, it may darken because of degradation of methyldopa or its metabolites.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other antihypertensive drugs.

When methyldopa is used in combination with other antihypertensive drugs, potentiation of antihypertensive action may occur. Patients should be carefully monitored for adverse reactions or unusual manifestations of drug idiosyncrasy.

Lithium.

When methyldopa and lithium are administered concomitantly, the patient should be followed carefully to detect symptoms of lithium toxicity.

Monoamine oxidase (MAO) inhibitors.

See Section 4.3 Contraindications.

Iron.

Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate. This may adversely affect blood pressure control in patients treated with methyldopa.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

See Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy.
(Category A)
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Methyldopa has been used under close medical and obstetric supervision for the treatment of hypertension during pregnancy. There was no clinical evidence that methyldopa caused foetal abnormalities or affected the neonate.
Methyldopa does cross the placental barrier and appears in cord blood.
Although no obvious teratogenic effects have been reported, the possibility of foetal injury cannot be excluded and the use of methyldopa in women who are or may become pregnant necessitates that anticipated benefits be weighed against possible risks.
Methyldopa appears in breast milk. Therefore, caution should be exercised if methyldopa is given to a breastfeeding mother.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia or weakness may be noted as early and transient symptoms.
Significant adverse effects due to methyldopa have been infrequent and this drug is usually well tolerated.
The following reactions have been reported:

Central nervous system.

Sedation (usually transient), headache, asthenia or weakness, paraesthesias, parkinsonism, Bell's palsy, involuntary choreoathetotic movements. Psychic disturbances, including nightmares, impaired mental acuity and reversible mild psychoses or depression. Dizziness, lightheadedness and symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure).

Cardiovascular.

Bradycardia, prolonged carotid sinus hypersensitivity, aggravation of angina pectoris, atrioventricular block. Orthostatic hypotension (the daily dosage should be reduced). Oedema (and weight gain) usually relieved by use of a diuretic (discontinue methyldopa therapy if oedema progresses or signs of heart failure appear).

Gastrointestinal.

Nausea, vomiting, distension, constipation, flatus, diarrhoea, colitis, mild dryness of mouth, sore or 'black' tongue, pancreatitis, sialoadenitis.

Hepatic.

Liver disorders including hepatitis, jaundice, abnormal liver function tests.

Haematological.

Positive Coombs test, haemolytic anaemia, bone marrow depression, leucopoenia, granulocytopenia, thrombocytopenia, eosinophilia. Positive tests for antinuclear antibody, LE cells, and rheumatoid factor.

Allergic.

Drug related fever and abnormal liver function tests with jaundice and hepatocellular damage (see Section 4.4 Special Warnings and Precautions for Use), lupus-like syndrome, myocarditis, pericarditis, angioedema, urticarial.

Dermatological.

Rash as in eczema or lichenoid eruption; toxic epidermal necrolysis.

Other.

Nasal stuffiness, rise in BUN, breast enlargement, gynaecomastia, lactation, hyperprolactinaemia, amenorrhoea, impotence, decreased libido, mild arthralgia with or without joint swellings, myalgia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, lightheadedness, constipation, distention, flatus, diarrhoea, nausea, vomiting).
In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function, and cerebral activity. Sympathomimetic drugs (e.g. levarterenol, noradrenaline, metaraminol bitartrate) may be indicated. Methyldopa is dialyzable.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Methyldopa is an effective antihypertensive agent that decreases both supine and standing blood pressure. Symptomatic postural hypotension, exercise hypotension and diurnal blood pressure variations rarely occur. By adjustment of dosage, morning hypotension can be prevented without sacrificing control of afternoon blood pressure.
Methyldopa has no direct effect on cardiac function and usually does not decrease glomerular filtration rate, filtration fraction, or renal blood flow. Cardiac output is usually maintained without cardiac acceleration. The heart rate is slowed in some patients.
Because of relative freedom from adverse effects on kidney function, methyldopa can be of benefit in the control of high blood pressure, even in the presence of renal impairment. It may help arrest or slow the progression of renal function impairment and damage due to sustained elevation of blood pressure.
Normal or elevated plasma renin activity may reduce in the course of methyldopa therapy.
Only methyldopa, the L-isomer of α-methyldopa, has the ability to inhibit dopa decarboxylase and to deplete animal tissue of noradrenaline. In man, the antihypertensive activity of methyldopa appears to be due solely to the L-isomer.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets also contain citric acid, disodium edetate, ethylcellulose, sodium starch glycollate, guar gum, colloidal anhydrous silica, magnesium stearate and Opadry Yellow OY-8462.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Container type: HDPE bottles.
Pack sizes: 30, 90, 100 and 500 film coated tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Methyldopa is a white to yellowish-white crystalline powder or almost colourless crystals. It is odourless and almost tasteless. It is slightly soluble in water and in ethanol (96%) and is practically insoluble in ether and in chloroform. It dissolves in dilute mineral acids.

Chemical structure.

The active ingredient of Hydopa is methyldopa, which is the L-isomer of α-methyldopa.

Chemical name.

(-)-3-(3,4-dihydroxyphenyl)- 2-methyl-L-alanine.

Molecular formula.

C₁₀H₁₃NO₄.1½H₂O.

Molecular weight.

238.2.

CAS number.

41372-08-1.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

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BRAND INFORMATION

Hydopa 250 mg