7 Agbor Close, Ajao Estate, Isolo Lagos
CSPC Ouyi Pharmaceutical Co., Ltd. No. 276 West Zhongshan Road, Shijiazhuang, China.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: A4-2976): Each tablet contains Methyldopa 250 mg. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3, 4-dihydroxyphenyl)-2-methylalanine.
Pack size: ALDOPRES is supplied in 250 mg and 500 mg tablets and packed in blisters of 10 x 10 tablets.
Methyldopa tablet is a coated tablet for oral dosage. Each tablet contains Methyldopa 250 mg. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3, 4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C10H13NO4,1H2O with a molecular weight of 238.2,
ACTION AND CLINICAL PHARMACOLOGY:
ALDOPRES (Methyldopa), an antihypertensive agent, is an aromatic-amino-acid decarboxylase inhibitol in animals and man. Only the L-isomer of alpha-methyldopa has this activity.
The antihypertensive effect of ALDOPRES (methyldopa) is due to its metabolism to alpha-rnethylnorepinephrine, which then lowers arterial pressure by stimulation of central inhibitory alpha-2-adrenergic receptors, false neurotransmission, and/or reduction of plasma rennin activity. ALDOPRES causes a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine and epinephrine
ALDOPRES has variable absorption from the gut of approximately 50%. lt is metabolized in the intestine and the liver into the active metabolite alpha-rnethylnorepinephrine which acts in the brain to stimulate alpha-2-adrenerqic receptors thereby decreasing total peripheral resistance. It is excreted in urine.
ALODPRES is indicated in mild, moderate and severe hypertension.
In cases of acute hypertensive crisis, treatment may be initiated with ALDOPRES injection (methyldopate hydrochloride).
Active hepatic disease, such as active cirrhosis, is a contraindication for use of ALDOPRES.
It is also contra-indicated in patients on monoamine oxidase (MAO) inhibitors.
ALDOPRES should be used with caution in patients with a history of previous liver disease or dysfunction.
ALDOPRES may interfere with some laboratory analysis.
For example methyldopa causes fluorescence in urine samples at the wave lengths as catecholamines thereby causing falsely high levels of catecholamines.
This will interfere with diagnosis of pheochromocytoma and is not recommended for treatment of patients with pheocromocytoma.
When ALDOPRES is used with other antihypertensive drugs, potentiation of antihypertensive effect may occur.
Patient should be followed carefully to detect side effects or unusual manifestations of drug idiosyncrasy.
Significant side effects due to ALDOPRES have been infrequent and the drug is usually well tolerated.
The following side effects have been reported.
CNS: Sedation (usually transient may occur during the initial period of therapy or whenever the dose is increased), headache, asthenia or weakness, dizziness, light headedness, symptoms of cerebrovascular insufficiency,
paresthesis. Psychic disturbances including night mares and reversible mild psychosis or depression.
CARDIOVASCULAR: bradycardia. prolonged carotid sinus hypersensitivity, and aggravation of angina pectoris.
Orthostatic hypotension, edema (and weight gain) usually relieved by use of a diuretic.
Dosage & Administration
The usual starting dose of ALDOPRES is 250 mg two top three times a day for the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than two days, until an adequate response is obtained. The maximum recommended daily dosage is 3 g.
ALDOPRES may also be administered concurrently with MODILAT (Hydrochlorothiazide and Amiloride) or beta (-) blocking agent such as BITENOL (Atenolol).
Many patients can be controlled with One tablet of MODILAT and 500 mg of AIDOPRES administered once daily.
Initial dose is based on 10 mg/kg of body weight daily in two to four doses. The daily dosage then is increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3.0 g daily, whichever is less.
Store in well-closed containers in a dry place at room temperature. Protect from light.
KEEP All MEDICINE OUT OF THE REACH OF CHILDREN.