Methyldopa and Hydrochlorothiazide

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Overview

What is Methyldopa and Hydrochlorothiazide?

This fixed combination product combines two antihypertensives: methyldopa and hydrochlorothiazide.

What does Methyldopa and Hydrochlorothiazide look like?

What are the available doses of Methyldopa and Hydrochlorothiazide?

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What should I talk to my health care provider before I take Methyldopa and Hydrochlorothiazide?

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How should I use Methyldopa and Hydrochlorothiazide?

Hypertension - (see ).

DOSAGE MUST BE INDIVIDUALIZED, AS DETERMINED BY TITRATION OF THE INDIVIDUAL COMPONENTS (see ). Once the patient has been successfully titrated, methyldopa and hydrochlorothiazide tablets may be substituted if the previously determined titrated doses are the same as in the combination. The usual starting dosage is one 250 mg/15 mg tablet of methyldopa and hydrochlorothiazide two or three times a day or one 250 mg/25 mg tablet of methyldopa and hydrochlorothiazide two times a day. Alternatively, one 500 mg/30 mg tablet of methyldopa and hydrochlorothiazide or a 500 mg/50 mg tablet of methyldopa and hydrochlorothiazide once daily may be used. Hydrochlorothiazide doses greater than 50 mg daily should be avoided.

Hydrochlorothiazide can be given at doses of 12.5 mg to 50 mg per day when used alone. The usual daily dosage of methyldopa is 500 mg to 2 g. To minimize the sedation associated with methyldopa, start dosage increases in the evening. The maximum recommended daily dose of methyldopa is 3 g.

Occasionally tolerance to methyldopa may occur, usually between the second and third month of therapy. Additional separate doses of methyldopa or replacement of methyldopa and hydrochlorothiazide tablets with single entity agents is necessary until the new effective dose ratio is reestablished by titration.

If methyldopa and hydrochlorothiazide does not adequately control blood pressure, additional doses of other agents may be given. When methyldopa and hydrochlorothiazide is given with antihypertensives other than thiazides, the initial dosage of methyldopa should be limited to 500 mg daily in divided doses and the dose of these other agents may need to be adjusted to effect a smooth transition.

Since both components, methyldopa and hydrochlorothiazide, have a relatively short duration of action, withdrawal is followed by return of hypertension usually within 48 hours. This is not complicated by an overshoot of blood pressure.

Since methyldopa is largely excreted by the kidney, patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.

What interacts with Methyldopa and Hydrochlorothiazide?

Methyldopa and hydrochlorothiazide tablets are contraindicated in patients:

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What are the warnings of Methyldopa and Hydrochlorothiazide?

Methyldopa

Hydrochlorothiazide

Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Thiazides may add to or potentiate the action of other antihypertensive drugs.

Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Lithium generally should not be given with diuretics (see ).

What are the precautions of Methyldopa and Hydrochlorothiazide?

General

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Laboratory Tests

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Blood count, Coombs test and liver function tests, are recommended before initiating therapy and at periodic intervals (see ).

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Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals.

Drug Interactions

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Drug/Laboratory Test Interactions

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Thiazides should be discontinued before carrying out tests for parathyroid function (see ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of the combination.

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Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of the combination.

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Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of the combination.

Pregnancy

Use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.

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Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in adults.

Nursing Mothers

Methyldopa and thiazides appear in breast milk. Therefore, because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of methyldopa and hydrochlorothiazide in pediatric patients has not been established.

Geriatric Use

Clinical studies of methyldopa and hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

What are the side effects of Methyldopa and Hydrochlorothiazide?

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

Methyldopa

Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia, or weakness may be noted as early and transient symptoms. However, significant adverse effects due to methyldopa have been infrequent and this agent usually is well tolerated.

Cardiovascular:

Digestive:

Endocrine:

Hematologic:

Hepatic:

Hypersensitivity:

Nervous System/Psychiatric:

Metabolic:

Musculoskeletal:

Respiratory:

Skin:

Urogenital:

Hydrochlorothiazide

What should I look out for while using Methyldopa and Hydrochlorothiazide?

Methyldopa and hydrochlorothiazide tablets are contraindicated in patients:

What might happen if I take too much Methyldopa and Hydrochlorothiazide?

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distention, flatus, diarrhea, nausea, vomiting).

In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.

Sympathomimetic drugs (e.g., norepinephrine, epinephrine, metaraminol bitartrate) may be indicated. Methyldopa is dialyzable. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

The oral LD of methyldopa is greater than 1.5 g/kg in both the mouse and the rat. The oral LD of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

How should I store and handle Methyldopa and Hydrochlorothiazide?

Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ Methyldopa and Hydrochlorothiazide Tablets, USP are available as follows:The 250 mg/15 mg tablets are green, round, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0507-01bottles of 100 tabletsThe 250 mg/25 mg tablets are green, capsule-shaped, unscored, film-coated tablets debossed with on one side and on the other side. They are available as follows:NDC 0378-0711-01bottles of 100 tabletsNDC 0378-0711-10bottles of 1000 tabletsStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED NOVEMBER 2005MDHZ:R5AQ

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Methyldopa is an aromatic-amino-acid decarboxylase inhibitor in animals and in man. Although the mechanism of action has yet to be conclusively demonstrated, the antihypertensive effect of methyldopa probably is due to its metabolism to alpha-methylnorepinephrine, which then lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity. Methyldopa has been shown to cause a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine, and epinephrine.

Only methyldopa, the -isomer of alpha-methyldopa, has the ability to inhibit dopa decarboxylase and to deplete animal tissues of norepinephrine. In man, the antihypertensive activity appears to be due solely to the -isomer. About twice the dose of the racemate (-alpha-methyldopa) is required for equal antihypertensive effect.

Methyldopa has no direct effect on cardiac function and usually does not reduce glomerular filtration rate, renal blood flow, or filtration fraction. Cardiac output usually is maintained without cardiac acceleration. In some patients the heart rate is slowed.

Normal or elevated plasma renin activity may decrease in the course of methyldopa therapy.

Methyldopa reduces both supine and standing blood pressure. It usually produces highly effective lowering of the supine pressure with infrequent symptomatic postural hypotension. Exercise hypotension and diurnal blood pressure variations rarely occur.

Non-Clinical Toxicology

Methyldopa and hydrochlorothiazide tablets are contraindicated in patients:

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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