Each Tablet contains Methyldopa 250mg
Methyldopa in Caldopa® Tablet act by stimulation of central alpha-adrenergic receptors by a false transmitter that results in a decreased sympathetic outflow to the heart, kidneys and peripheral vasculature.
Caldopa® is indicated in the management of moderate to severe hypertension, including that complicated by renal disease.
Caldopa® is contraindicated in patients with:
- Active hepatic disease, such as acute hepatitis and active cirrhosis.
- Hypersensitivity to methyldopa or any component of the formulation.
- On therapy with monoamine oxidase inhibitors (MAOIs).
ANAEMIA: Acquired haemolytic anaemia has occurred rarely; should symptoms suggest anaemia, haemoglobin and/or haematocrit determinations should be made.
If anaemia is confirmed test should be done for haemolysis. If haemolytic anaemia is present, methyldopa should be discontinued.
FEVER, ABNORMALITY IN LIVER FUNCTION OR JAUNDICE
Occassionally, fever has occurred within the first three weeks of therapy, sometimes associated with cosinophilia or abnormalities in liver-function test, jaundice, with or without fever, also may occur, its onset is usually within the first two or three months of therapy.
Should fever, abnormality in liver function, or jaundice occur therapy should be withdrawn. If related to methyldopa, the temperature and abnormalities in liver function will then return to normal. Methyldopa should not be used again in these patients. Methyldopa should be used with caution in patients with a history of previous liver disease or dysfunction.
DENTAL: Use of methyldopa may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candiasis and discomfort.
KEEP OUT OF THE REACH OF CHILDREN!
Peripheral Edema (swelling of feet or lower legs)
Drug fever (fever shortly after onset of therapy)
Mental status changes (mental depression or anxiety, nightmares or usually vivid dreams).
Drowsiness, dryness of mouth, headache, cholestasis or hepatitis and hepatocellular injury.
Decreased sexual ability or interest in sex (more common in men than in women), diarrhea, hyperprolactinemia ( swelling of breast or unusual milk production), nausea or vomiting, orthostatic hypotension (dizziness or light headedness when getting up from a lying or sitting position), paresthesias (numbness, tingling, pain or weakness in hands or feet); sinus bradycardia (slow heartbeat) and stuffy nose.
LITHIUM: When methyldopa and Lithium are given concomitantly the patient should be monitored carefuuly for symptoms of Lithium toxicity.
OTHER ANTI HYPERTENSIVE DRUGS: When Caldopa® is used with other anti hypertensive drugs, potentiation of anti hypertensive action may occur. The progress of patients should be carefully followed to detect side relations or manifestations of drug idiosyncrasy.
OTHER CLASSES OF DRUG: The anti hypertensive effect of Caldopa® may be diminished by sympathomimetics, phenothiazines, tricyclic anti depressants and monoamine oxidase inhibitors (MAOIs). In addition phenothiazines may have hypotensive effects.
IRON: Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulphate or ferrous gluconate. This may adversely affect blood pressure control in patients with methyldopa.
DOSAGE AND ADMINISTRATION
ADULT DOSE: Initial Dosage: One tablet (250mg) 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.
500mg to 2 grams a day, divided into two or four doses.
The maximum recommended daily dosage is 3g.
PAEDIATRIC DOSE: Initial dosage is based on 10mg/kg of body weight daily in two to four divided doses. The daily dosage is then increased or decreased until an adequate response is achieved. The maximum dosage is 65mg/kg or 3.0g daily which ever is less.
GERIATRIC OR ELDERLY DOSE: The initial dose in elderly patients should be kept as low as possible, not exceeding 250mg daily; an appropriate starting dose in the elderly would be 125mg two times daily increasing slowly as required, but not to exceed a maximum daily dosage of 2g.
Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.
Store below 30OC. Protect from light.
Caldopa® is available as tablets containing 250mg methyldopa in a blister of 10 X 10’s per pack.