Brand Name :
Aldoril 15, Aldoril 25,Aldoril D50,Aldoril 30
Synonyms :
methyldopa/hydrochlorothiazide
Class :
Antihypertensive; Diuretic, Thiazide
Dosage Forms & Strengths
Tablet
250mg/15mg
250mg/25mg
methyldopa 500mg/hydrochlorothiazide 30 to 50mg orally every day
methyldopa 250mg/hydrochlorothiazide 25mg orally twice a day or
methyldopa 250mg/hydrochlorothiazide 15mg orally twice or thrice a day
Do not exceed 50mg of hydrochlorothiazide every day
Dose Adjustments
Renal impairment
In patients with creatinine clearance (CrCl) of less than 30 mL/min, valsartan/hydrochlorothiazide should be avoided due to the potential for azotemia (elevated blood urea nitrogen and creatinine levels)
Safety and efficacy not established
A dose decrease may be indicated based on the patient’s renal function
may increase the hypotensive effect of blood pressure-lowering agents
may increase the hypotensive effect of thiazide and thiazide like diuretics
may enhance the toxic effect of thiazide and thiazide like diuretics
may increase the AV blocking effect of alpha2 agonists
may diminish the absorption of thiazide and thiazide like diuretics
may diminish the serum concentration of methyldopa
may diminish the serum concentration of methyldopa
may diminish the serum concentration of methyldopa
may diminish the serum concentration of methyldopa
l-methylfolate-pyridoxal 5′-phosphate-methylcobalamine
may diminish the serum concentration of methyldopa
may decrease the antihypertensive effect of alfa 2 agonist
may increase the toxic effect of methyldopa
may increase the toxic effect of methyldopa
may increase the toxic effect of methyldopa
may increase the toxic effect of methyldopa
may increase the toxic effect of methyldopa
may increase the hypotensive effect of blood pressure-lowering agents
may increase the hypotensive effect of blood pressure-lowering agents
may increase the hypotensive effect of blood pressure-lowering agents
may increase the hypotensive effect of blood pressure-lowering agents
may increase the hypotensive effect of blood pressure-lowering agents
may diminish the therapeutic effect of thiazide and thiazide like diuretics
may diminish the therapeutic effect of thiazide and thiazide like diuretics
may diminish the therapeutic effect of thiazide and thiazide like diuretics
may diminish the therapeutic effect of thiazide and thiazide like diuretics
may diminish the therapeutic effect of thiazide and thiazide like diuretics
may increase the neuromuscular blocking effect of thiazide and thiazide like diuretics
may increase the neuromuscular blocking effect of thiazide and thiazide like diuretics
may increase the neuromuscular blocking effect of thiazide and thiazide like diuretics
may increase the neuromuscular blocking effect of thiazide and thiazide like diuretics
may increase the neuromuscular blocking effect of thiazide and thiazide like diuretics
Mechanism of action and spectrum
methyldopa and hydrochlorothiazide treat hypertension (high blood pressure) in adults. By working together, these two medications can help to lower blood pressure by reducing the amount of fluid in the body, relaxing blood vessels, and decreasing sympathetic nervous system activity
Frequency undefined:
methyldopa
arthralgia
orthostatic hypotension
dizziness
sedation
gynecomastia
dry mouth
hemolytic anemia
angina
bradycardia
depression
lethargy
rash
impotence
nausea
hydrochlorothiazide
epigastric distress
orthostatic hypotension
anaphylaxis
confusion
steven johnson syndrome
hypomagnesemia
headache
anorexia
hypotension
photosensitivity
anemia
erythema multiforme
dizziness
hyperuricemia
Black box warning
Not recommended for use as the first line of treatment for hypertension; before starting treatment, the patient must be evaluated to establish the appropriate dosage for each specific agent; usage might make patient management more practical
Contraindications
The combination of methyldopa and hydrochlorothiazide is contraindicated in patients with a known hypersensitivity to either drug or any of their components, in patients with a history of hepatic disease or hepatic dysfunction, and patients with anuria or severe renal impairment
Caution
The combination of methyldopa and hydrochlorothiazide should be used with caution in patients with impaired renal function, hepatic dysfunction, or a history of electrolyte imbalances. It may also cause orthostatic hypotension, especially in elderly patients, and should be used with caution in patients taking other antihypertensive medications
Pregnancy consideration: C
Lactation: Excretion of the drug in human breast milk is known
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology
methyldopa and hydrochlorothiazide have complementary mechanisms of action, resulting in a more significant antihypertensive effect than either drug alone. methyldopa can help to control blood pressure by reducing peripheral resistance, while hydrochlorothiazide can help to reduce blood volume through diuresis. However, because methyldopa and hydrochlorothiazide have different pharmacological profiles, this combination is necessary to monitor blood pressure and renal function
Pharmacodynamics
methyldopa reduces peripheral resistance and cardiac output, while hydrochlorothiazide reduces blood volume through diuresis. This combination results in a more significant reduction in blood pressure than either drug alone
Pharmacokinetics
Absorption
methyldopa is absorbed from the gastrointestinal tract after oral administration, with a bioavailability of around 50%.hydrochlorothiazide is well absorbed from the gastrointestinal tract after oral administration, with a bioavailability of about 70%.
Distribution
methyldopa has a low volume of distribution (0.23 L/kg) and is highly protein-bound (about 10-15%). hydrochlorothiazide has a moderate volume of distribution (3.6-7.8 L/kg) and is moderately protein-bound (about 68%).
Metabolism
methyldopa undergoes extensive hepatic metabolism to form several metabolites, including alpha-methylnorepinephrine, which is thought to be the active metabolite responsible for its antihypertensive effects. hydrochlorothiazide is minimally metabolized in the liver.
Elimination/Excretion
methyldopa and its metabolites are primarily excreted in the urine. hydrochlorothiazide is primarily excreted unchanged in the urine. Its elimination half-life is 6-15 hours.
Administration
methyldopa is usually taken orally two to three times a day, while hydrochlorothiazide is taken once daily, usually in the morning
Patient information leaflet
Generic Name: methyldopa/hydrochlorothiazide
Pronounced: [ HYE-droe-KLOR-oh-THYE-a-zide-and-METH-il-DOE-pa ]
Why do we use methyldopa/hydrochlorothiazide?
methyldopa and hydrochlorothiazide are both medications used to treat high blood pressure (hypertension)
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