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Aldomet

Aldomet

Aldomet (methyldopa) is a trusted FDA-approved medication for managing hypertension, effectively reducing blood pressure by relaxing blood vessels. It is suitable for adults and neonates and offers flexible dosing options in both injectable and tablet forms. With a favorable safety profile, Aldomet is especially beneficial for patients seeking a well-tolerated treatment. When used under medical supervision, it provides reliable blood pressure control, contributing to cardiovascular health and reducing the risk of hypertension-related complications.

Product Overview

Aldomet (methyldopa) is an FDA-approved medication primarily used to treat high blood pressure (hypertension). It is available in injectable solution (50mg/ml) and tablet form (250mg and 500mg). Adults typically start with a dose of 250 mg orally every 8-12 hours, which can be adjusted based on response. For hypertensive crises, the dosage may be higher. Dosage adjustments are also recommended for those with renal impairment.

In treating hypertension, the usual dosage is 2.5-5 mg/kg orally or intravenously every 8 hours. It is essential to take Aldomet as prescribed, at the exact times each day, and continue taking it even if you feel well. Aldomet works by stimulating the central nervous system to reduce the activity of the sympathetic nervous system, leading to relaxed blood vessels and lower blood pressure. Common side effects include lightheadedness, drowsiness, and headaches.

Patients with a history of liver disease or dysfunction should use Aldomet with caution. During treatment, it is also essential to monitor for signs of hemolytic anemia and liver disorders. This medication should be stored at room temperature, away from light and moisture, and out of reach of children and pets. Patients with active liver diseases should not use it, those allergic to its components, or those taking monoamine oxidase inhibitors.

Uses of Aldomet

  • Used in the treatment of hypertension (high blood pressure).

How to Use Aldomet?

Dosage

Strengths and Forms

Injectable solution

  • 50mg/ml

Tablet

  • 250mg
  • 500mg

Recommended Dosage for Aldomet

Adult

For hypertension:

  • Initially, take 250 mg orally every 8-12 hours for 2 days, then increase as needed every 2 days.
  • For maintenance, take 250-1000 mg per day orally, divided into doses every 6-12 hours, usually not exceeding 3 g per day.
  • For IV administration (methyldopate), infuse 250-1000 mg over 30-60 minutes every 6-8 hours as needed, not exceeding 4 g per day.

For hypertensive crisis:

  • Administer 20-40 mg/kg per day intravenously, divided into doses every 6 hours.
  • Do not exceed 65 mg/kg per day or 3 g per day, whichever is less.

For renal impairment:

  • Adjust the dosage frequency based on renal function.
  • If creatinine clearance (CrCl) exceeds 50 ml/min, administer every 8 hours.
  • If CrCl is 10-50 ml/min, allocate every 8-12 hours.
  • If CrCl is less than 10 ml/min, administer every 12-24 hours.

Pediatric

For hypertension in neonates:

  • Administer 2.5-5 mg/kg orally or intravenously every 8 hours.
  • Start with 10 mg/kg per day orally, divided into doses every 12 hours, and increase as needed every 2 days.

For hypertensive crisis:

  • Administer 20-40 mg/kg intravenously daily, divided into doses every 6 hours.
  • Do not exceed 65 mg/kg per day or 3 g per day, whichever is less.

Geriatric

For hypertension:

  • Lower initial doses and more gradual adjustments are recommended.
  • Start with 125 mg once daily or every 12 hours. The dose may be increased by increments of 125 mg every 2-3 days as needed.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they will customize your dosage accordingly.]

How to Take It?

Follow these instructions to take Aldomet (methyldopa):

  • Take this medication orally, with or without food.
  • Typically, it is taken 2 to 4 times daily.
  • Begin this medication or any increase in dosage in the evening to reduce the risk of side effects.
  • If the doses are unequal, take the larger dose at bedtime.
  • The dosage depends on your medical condition and how you respond to treatment.
  • Take this medication consistently for the best results.
  • To aid in remembering, take it at the same time each day.
  • Continue taking this medication even if you feel well.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Aldomet Work?

Aldomet (methyldopa) works by stimulating the central nervous system to produce alpha-2 adrenergic receptors, which in turn reduce the activity of the sympathetic nervous system. This leads to a decrease in the release of norepinephrine, a neurotransmitter responsible for increasing blood pressure. As a result, blood vessels relax and dilate, leading to a reduction in blood pressure. methyldopa also acts directly on the blood vessels, causing them to relax and further lowering blood pressure.

Important Safety Information

Side Effects

Common Side Effects

  • Lightheadedness
  • Drowsiness
  • Headache
  • Stuffy nose
  • Weakness, especially when starting this medication and when the dosage is increased.

Adverse/Serious Side Effects

  • Lightheadedness
  • Pale or yellowed skin
  • Dark-colored urine
  • Fever
  • Confusion
  • Vomiting
  • Dark urine
  • Swelling
  • Nausea
  • Weakness
  • Fast heart rate
  • Loss of appetite
  • Rapid weight gain
  • Shortness of breath
  • Uncontrolled or involuntary muscle movements
  • Upper stomach pain leading to pain in the back
  • Yellowing of the skin or eyes (jaundice)

[Note: This list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

  • Methyldopa therapy may result in a positive Coombs test, hemolytic anemia, and liver disorders. These conditions can lead to severe complications if not properly managed.
  • 10 to 20 percent of patients on methyldopa develop a positive direct Coombs test, usually between 6 and 12 months of therapy. The risk is lowest with a daily dosage of 1g or less.
  • A positive direct Coombs test does not always indicate hemolytic anemia but can be associated with it.
  • Before starting methyldopa, it is advisable to perform a blood count for a baseline and periodically during therapy to detect hemolytic anemia. A direct Coombs test should also be done before treatment and 6 and 12 months after starting.
  • If Coombs-positive hemolytic anemia occurs, methyldopa should be discontinued. The anemia usually remits promptly, but corticosteroids may be needed if it does not.
  • Conducting direct and indirect Coombs tests is essential for patients needing a transfusion. A positive direct Coombs test does not impact the blood typing or cross-matching process.
  • Fever, sometimes with eosinophilia or liver function abnormalities, may occur within the first 3 weeks of therapy. Jaundice may appear within the first 2 to 3 months.
  • Rarely fatal hepatic necrosis has been reported. Periodic liver function tests are recommended, especially during the first 6 to 12 weeks of therapy or if unexplained fever occurs. If abnormalities or jaundice appear, methyldopa should be stopped.
  • Reversible reductions in white blood cell count, primarily affecting granulocytes, and rare cases of granulocytopenia and thrombocytopenia have been reported. These counts return to normal upon discontinuation of the drug.

Precautions

General:

  • Use methyldopa cautiously in patients with a history of liver disease or dysfunction.
  • Some patients may experience swelling or weight gain, which can be managed with a diuretic. Discontinue methyldopa if swelling progresses or heart failure symptoms appear.
  • Blood pressure may rise after dialysis in patients taking methyldopa, as the drug is removed during the procedure.
  • Rarely, involuntary movements may occur in patients with severe cerebrovascular disease. Stop therapy if these movements occur.

Laboratory Tests:

  • Perform blood count, Coombs test, and liver function tests before starting therapy and periodically during treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

  • No evidence of tumor formation was seen in mice and rats given methyldopa for two years.
  • methyldopa was not mutagenic in the Ames Test and did not increase chromosomal abnormalities in Chinese hamster ovary cells.
  • Fertility was unaffected in rats at 100 mg/kg/day, but higher doses decreased sperm count and male fertility index.

Pregnancy:

  • methyldopa falls under Category B for pregnancy, with no evidence of harm to the fetus in animal studies.
  • Limited human studies suggest that methyldopa may improve fetal outcomes during pregnancy.
  • Use methyldopa during pregnancy only if necessary.

Nursing Mothers:

  • methyldopa is present in breast milk. Use caution when prescribing methyldopa to nursing mothers.

Pediatric Use:

  • There are no well-controlled clinical trials in pediatric patients. Dosing information is based on published literature on treating hypertension in children.

Aldomet Contraindications

Aldomet (methyldopa) should not be used by patients who have:

  • Active liver diseases like acute hepatitis and active cirrhosis.
  • Previously experienced liver disorders related to methyldopa therapy.
  • Allergic to any ingredient in these products.
  • Are currently taking monoamine oxidase (MAO) inhibitors.

Missed Dose

If you forget to take a dose, take it as soon as you remember. However, if your next dose is approaching, skip the missed dose. Taking two doses at the same time is not advisable and can lead to an overdose of the medication.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Symptoms of an overdose might include severe drowsiness, vomiting, slow heartbeat, or fainting.

[Note: If you consumed more than the recommended dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

  • Store Aldomet (methyldopa) at average temperature.
  • Keep it where it is not exposed to light and moisture.
  • Avoid storing it in the bathroom.
  • Store all medications out of reach of children and pets.
  • Avoid disposing of medications by flushing them down the toilet or pouring them into a drain unless instructed.
  • Dispose of this product properly when it has expired or is no longer needed.

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

Aldomet Interactions

Aldomet (methyldopa) can interact with several other medications. Here are some potential interactions:

  • Monoamine Oxidase Inhibitors (MAOIs)
  • Lithium
  • Haloperidol
  • Levodopa
  • Tolbutamide
  • Respiratory Medicines
  • Beta-Blockers
  • Phenothiazines
  • Barbiturates
  • Tricyclic Antidepressants

[Note: This is not a complete list, and there could be other drugs that interact with Aldomet. Please tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Aldomet Alternatives

[Note: Your doctor will prescribe the most suitable medication for you. Only use these alternative medications after consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Is Aldomet available without a prescription?

No, Aldomet is a prescription medication and cannot be obtained without a valid prescription from a licensed healthcare provider. It’s essential to discuss with a doctor before starting or adjusting any medication regimen, including Aldomet. This ensures that the medication is suitable for your specific medical condition, taken in the correct dosage, and under proper medical supervision.

Are there any age restrictions for using Aldomet?

Aldomet may not be suitable for individuals under 18 due to insufficient data regarding its safety and efficacy in this age group. It is important to consult a medical practitioner before administering Aldomet to individuals under 18. Always seek the help of a healthcare provider to determine the appropriate treatment for any individual, considering their medical history and condition.

What are the long-term effects of taking Aldomet?

Long-term use of Aldomet (methyldopa) may lead to potential side effects. These include impaired kidney function, increased susceptibility to infections, and anemia. Additionally, some individuals may experience dizziness, fatigue, and swelling. Individuals on long-term Aldomet therapy must undergo regular medical check-ups to monitor for any emerging issues and adjust treatment as necessary. Close medical supervision is essential to ensure the medication’s effectiveness and promptly address any potential long-term effects.

What should you avoid while on methyldopa?

  • Avoid taking methyldopa with monoamine oxidase inhibitors (MAOIs) such as isocarboxazid, phenelzine, linezolid, and tranylcypromine.
  • Be cautious, as methyldopa can be linked to a severe blood disorder known as hemolytic anemia.

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