Methyldopa 500mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Methyldopa (anhydrous)

Disponível em:

Sigma Pharmaceuticals Plc

Código ATC:

C02AB01

DCI (Denominação Comum Internacional):

Methyldopa (anhydrous)

Dosagem:

500mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050200

Folheto informativo - Bula

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Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methyldopa 500mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains Methyldopa equivalent to 500mg anhydrous
methyldopa.
Excipients with known effect: Also contains lactose monohydrate and
sunset yellow
(E110).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablets
Yellow, circular, normal convex, film-coated tablets with breakline on
one side.
The breakline is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Use in adults: _
_Initial dosage:_ Usually 250 mg two or three times a day, for two
days.
_Adjustment_: Usually adjusted at intervals of not less than two days,
until an adequate
response is obtained. The maximum recommended daily dosage is 3 g.
Many patients experience sedation for two or three days when therapy
with
methyldopa is started or when the dose is increased. When increasing
the dosage,
therefore, it may be desirable to increase the evening dose first.
Withdrawal of methyldopa is followed by return of hypertension,
usually within 48
hours. This is not complicated generally by an overshoot of blood
pressure.
_Patients with renal impairment: _
Methyldopa is largely excreted by the kidney, and patients with
impaired renal
function may respond to smaller doses.
_Other antihypertensives: _
Therapy with methyldopa may be initiated in most patients already on
treatment with
other antihypertensive agents by terminating these antihypertensive
medications
gradually, as required. Following such previous antihypertensive
therapy, methyldopa
should be limited to an initial dose of not more than 500 mg daily and
increased as
required at intervals of not less than two days.
When methyldopa is given to patients on other antihypertensives the
dose of these
agents may need to be adjusted to effect a smooth transition.
When 500 mg of methyldopa is added to 50 mg o