Таблетки, покрытые оболочкой; Драже
Таблетки
Внутрь, начальная доза взрослым 250 мг 2–3 раза в день. Максимальная суточная доза 3 г. Детям по 10 мг/кг в сутки (в 2–4 приема).
Внутрь. Терапия препаратом Alfamet® требует индивидуального подбора дозы. Препарат можно принимать как до, так и после еды.
Взрослые пациенты. Рекомендованная начальная доза препарата Alfamet® в первые 2 дня терапии составляет 250 мг 2–3 раза в сутки. Затем дозу можно постепенно увеличить или уменьшить (в зависимости от степени снижения АД). Продолжительность интервалов между повышением и снижением дозы препарата Alfamet® должна составлять не менее 2 дней. Поскольку в течение 2–3 дней после начала терапии, а также при последующем увеличении дозы может наблюдаться побочное седативное влияние препарата, рекомендуется сначала увеличивать вечернюю дозу препарата.
Стандартная поддерживающая доза препарата Alfamet® составляет 500–2000 мг/сут. Эта доза делится на 2–4 приема. Максимальная суточная доза препарата не должна превышать 3000 мг. В случаях, когда на фоне приема препарата в дозе 2000 мг/сут отмечается недостаточно эффективное снижение уровня АД, рекомендуется комбинировать Alfamet® с другими антигипертензивными препаратами.
Спустя 2–3 мес терапии к метилдопе может выработаться толерантность. Эффективное снижение уровня АД может быть достигнуто за счет увеличения дозы препарата или сопутствующего применения диуретиков.
Спустя 48 ч после прекращения терапии препаратом Alfamet® АД обыкновенно возвращается к исходному уровню. «Эффект рикошета» при этом не наблюдается.
Препарат Alfamet® можно назначать пациентам, которые уже получают терапию другими антигипертензивными препаратами, при условии постепенной отмены этих препаратов. В таких случаях начальная доза препарата Alfamet® не должна превышать 500 мг/сут. Увеличение дозы осуществляется по мере необходимости, с интервалами не менее 2 дней.
При применении препарата Alfamet® в дополнение к ранее назначенной антигипертензивной терапии, для того чтобы гарантировать плавный переход, может потребоваться коррекция доз гипотензивных препаратов.
Пожилые пациенты. Пожилым пациентам препарат назначается в минимальной начальной дозе, которая не должна превышать 250 мг/сут. При необходимости дозу можно постепенно увеличивать. Продолжительность интервалов между повышением дозы препарата составляет не менее 2 дней. Максимальная суточная доза препарата Alfamet® не должна превышать 2000 мг.
У пожилых пациентов чаще наблюдаются обмороки. Это может быть связано с повышенной восприимчивостью к препарату и выраженным атеросклеротическим поражением сосудов. Развития обмороков можно избежать за счет снижения дозы препарата Alfamet®.
Дети старше 3 лет. Для детей начальная доза препарата составляет 10 мг/кг/сут. Суточная доза делится на 2–4 приема. При необходимости дозу можно постепенно увеличивать, пока не будет достигнут желаемый эффект. Между повышением дозы препарата необходимо соблюдать интервал не менее 2 дней. Максимальная суточная доза препарата Alfamet® составляет 65 мг/кг/сут, но не более 3 г/сут.
Нарушения функции почек. Метилдопа выводится преимущественно почками, поэтому при лечении больных с нарушенной функцией почек дозу препарата Alfamet® необходимо снижать. При легкой почечной недостаточности (скорость клубочковой фильтрации (СКФ) 60–89 мл/мин/1,73 м2) интервал между приемами препарата рекомендуется увеличить до 8 ч, при почечной недостаточности средней тяжести — до 8–12 ч (СКФ 30–59 мл/мин/1,73 м2), а при тяжелой почечной недостаточности — до 12–24 ч (СКФ <30 мл/мин/1,73 м2).
Метилдопа удаляется из организма при диализе, поэтому рекомендуется использовать добавочную дозу препарата 250 мг для профилактики увеличения уровня АД после сеанса гемодиализа.
Alfamet
Although the mechanism of action has yet to be conclusively demonstrated, the resultant hypotensive effect is most likely due to the drug’s action on the CNS. Alfamet is converted into the metabolite, alpha-methylnorepinephrine, in the CNS, where it stimulates the central inhibitory alpha-adrenergic receptors, leading to a reduction in sympathetic tone, total peripheral resistance, and blood pressure. Reduction in plasma renin activity, as well as the inhibition of both central and peripheral norepinephrine and serotonine production may also contribute to the drug’s antihypertensive effect, although this is not a major mechanism of action. This is done through the inhibition of the decarboxylation of dihydroxyphenylalanine (dopa)- the precursor of norepinephrine, 5-hydroxytryptophan (5-HTP), serotonin (in the CNS) and in most peripheral tissues.
Antihypertensive effects of methyldopa are mostly mediated by its pharmacologically active metabolite, alpha-methylnorepinephrine, which works as an agonist at central inhibitory alpha-adrenergic receptors. Stimulation of alpha-adrenergic receptors leads to decreased peripheral sympathetic tone and reduced arterial pressure. Alfamet causes a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine, and epinephrine. Overall, methyldopa lowers both standing blood pressure and especially supine blood pressure, with infrequent symptomatic postural hypotension. Alfamet also reduces plasma renin activity but has negligible effects on glomerular filtration rate, renal blood flow, or filtration fraction. It also has no direct effect on cardiac function but in some patients, a slowed heart rate may occur.
Following oral administration, blood-pressure-lowering effects are observed within 12 to 24 hours in most patients, and a maximum reduction in blood pressure occurs in 4 to 6 hours. Blood pressure returns to pre-treatment levels within 24 to 48 hours following drug discontinuation. Following intravenous administration, the blood-pressure-lowering effects of methyldopa last for about 10 to 16 hours.
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Uses
Alfamet is used for Hypertension
Alfamet is also used to associated treatment for these conditions: High Blood Pressure (Hypertension), Hypertensive crisis
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How Alfamet works
The exact mechanism of methyldopa is not fully elucidated; however, the main mechanisms of methyldopa involve its actions on alpha-adrenergic receptor and the aromatic L-amino acid decarboxylase enzyme, to a lesser extent. The sympathetic outflow is regulated by alpha (α)-2 adrenergic receptors and imidazoline receptors expressed on adrenergic neurons within the rostral ventrolateral medulla. Alfamet is metabolized to α‐methylnorepinephrine via dopamine beta-hydroxylase activity and, consequently, alpha-methylepinephrine via phenylethanolamine-N-methyltransferase activity. Mediating the therapeutic effects of methyldopa, α‐methylnorepinephrine and α-methylepinephrine active metabolites are agonists at presynaptic alpha-2 adrenergic receptors in the brainstem. Stimulating alpha-2 adrenergic receptors results in the inhibition of adrenergic neuronal outflow and attenuation of norepinephrine release in the brainstem. Consequently, the output of vasoconstrictor adrenergic signals to the peripheral sympathetic nervous system is reduced, leading to a reduction in blood pressure.
The L-isomer of alpha-methyldopa also reduces blood pressure by inhibiting aromatic L-amino acid decarboxylase, also known as DOPA decarboxylase, which is an enzyme responsible for the syntheses of dopamine and serotonin. Inhibiting this enzyme leads to depletion of biogenic amines such as norepinephrine. However, inhibition of aromatic L-amino acid decarboxylase plays a minimal role in the blood-pressure‐lowering effect of methyldopa.
Alfamet
| Trade Name | Alfamet |
| Availability | Prescription only |
| Generic | Methyldopa |
| Methyldopa Other Names | Alpha medopa, alpha-Methyl dopa, Alphamethyldopa, L-alpha-Methyldopa, L-Methyl Dopa, Methyl dopa, Methyldopa, metildopa |
| Related Drugs | amlodipine, lisinopril, metoprolol, losartan, furosemide, hydrochlorothiazide, hydralazine, nifedipine, captopril, enalapril |
| Type | |
| Formula | C10H13NO4 |
| Weight | Average: 211.2145 Monoisotopic: 211.084457909 |
| Protein binding |
Methyldopa is less than 15% bound to plasma proteins and its primary metabolite, O-sulfate metabolite, is about 50% protein bound. Following intravenous administration, approximately 17% of the dose in normal subjects were circulating in the plasma as free methyldopa. |
| Groups | Approved |
| Therapeutic Class | Centrally acting antihypertensive drugs (central sympatholytic) |
| Manufacturer | |
| Available Country | Turkey |
| Last Updated: | June 22, 2022 at 11:59 pm |
Structure
Table Of contents
- Alfamet
- Uses
- Dosage
- Side Effect
- Precautions
- Interactions
- Uses during Pregnancy
- Uses during Breastfeeding
- Accute Overdose
- Food Interaction
- Half Life
- Volume of Distribution
- Clearance
- Interaction With other Medicine
- Contradiction
- Storage
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Dosage
Alfamet dosage
Adult Use-
Initiation of Therapy: The usual starting dosage of Alfamet is 250 mg two or three times a day in 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 achieved. To minimize the sedation, start dosage increases in the evening. When Alfamet is given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When Alfamet is given with antihypertensives other than thiazides, the initial dosage of Alfamet should be limited to 500 mg daily in divided doses; when Alfamet is added to a thiazide, the dosage of thiazide need not to be changed.
Maintenance Therapy: The usual daily dosage of Alfamet is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 gm. Occasionally tolerance may occur, usually between the second and third month of therapy. Adding a diuretic or increasing the dosage of Alfamet frequently will restore effective control of blood pressure. A thiazide may be added at any time during Alfamet therapy and is recommended if therapy has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2 gm of Alfamet daily. Alfamet is largely excreted by the kidney and 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.
Pediatric Use-
Initial dosage 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 gm daily, whichever is less.
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Side Effects
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. The following systemic side effects may rarely occurs with the use of Alfamet — angina pectoris, congestive heart failure, orthostatic hypotension, edema or weight gain, bradycardia, pancreatitis, colitis, vomiting, diarrhea, nausea, constipation, dryness of mouth, hyperprolactinemia, bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia; rheumatoid factor, hepatitis, jaundice, myocarditis, pericarditis, vasculitis, eosinophilia, parkinsonism, bell’s palsy, nightmares and reversible mild psychoses or depression, dizziness, lightheadedness, paresthesias, arthralgia, myalgia, nasal stuffiness, rash, amenorrhea, gynecomastia, lactation, impotence. However, significant adverse effects due to Alfamet have been infrequent and this agent usually is well tolerated.
Toxicity
The lowest published toxic dose via oral route is 44 gm/kg/3Y (intermittent) in a female. Oral LD50 is 5000 mg/kg in rats and 5300 mg/kg in mice. Intraperitoneal LD50 is 300 mg/kg in rats and 150 mg/kg in mice.
Acute overdosage is characterized by acute hypotension and other presentations attributed to the brain and gastrointestinal dysfunction, such as excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distention, flatus, diarrhea, nausea, and vomiting. Symptomatic and supportive measures should be initiated in the event of methyldopa overdose. Overdosage following recent oral ingestion can be managed by gastric lavage or emesis, as well as infusions to limit further drug absorption. Cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity should be closely monitored. The use of sympathomimetic drugs such as levarterenol, epinephrine, and metaraminol bitartrate, or dialysis may be considered.
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Precaution
Patient with history of haemolytic anaemia, liver disease or depression; parkinsonism, hepatic porphyria. Not intended for the treatment of phaeochromocytoma. Renal or hepatic impairment. Childn, elderly. Pregnancy and lactation.
Interaction
When Alfamet is used with other antihypertensive drugs, potentiation of antihypertensive effect may occur. Patients may require reduced doses of anesthetics when on Alfamet. When Alfamet and lithium are given concomitantly the patient should be carefully monitored for symptoms of lithium toxicity. Coadministration of Alfamet with ferrous sulfate or ferrous gluconate is not recommended.
Food Interaction
- Take with or without food. Drug pharmacokinetics is unaffected.
Alfamet multivitamins interaction
[Moderate] ADJUST DOSING INTERVAL: The oral bioavailability and pharmacologic effects of methyldopa may be decreased during concurrent administration with iron-containing products.
The proposed mechanism is chelation of methyldopa by the iron cation, forming an insoluble complex that is poorly absorbed from the gastrointestinal tract.
In one study, five hypertensive patients receiving chronic methyldopa therapy (250 mg to 1500 mg daily) all had elevated blood pressure following the addition of ferrous sulfate 325 mg three times daily for 2 weeks.
The systolic pressure had increased by more than 15 mmHg in three of the patients and the diastolic pressure increased by more than 10 mmHg in two.
Blood pressure returned to baseline within 7 days of discontinuing the iron.
In 12 normal subjects, administration of methyldopa 500 mg with ferrous sulfate 325 mg or ferrous gluconate 600 mg resulted in an 88% and 79% reduction, respectively, in the renal excretion of unmetabolized, free methyldopa compared to administration of methyldopa alone.
In another study, administration of ferrous sulfate simultaneously with methyldopa reduced the bioavailability of methyldopa by 83%, while administration one hour or two hours before methyldopa reduced its bioavailability by 55% and 42%, respectively.br>
Until more information is available, patients receiving methyldopa in combination with iron-containing products should be advised to separate the times of administration by as much as possible.
Patients should be monitored closely for altered hypertensive effect and methyldopa dosage increased as necessary.
Selection of an alternative antihypertensive therapy may be necessary.
Alfamet Drug Interaction
Moderate: multivitamin, prenatal
Unknown: aspirin, aspirin, amoxicillin / clavulanate, diphenhydramine, calcium / vitamin d, omega-3 polyunsaturated fatty acids, furosemide, atorvastatin, acetaminophen, montelukast, levothyroxine, acetaminophen, valproic acid, thiamine, cyanocobalamin, pyridoxine, ascorbic acid, cholecalciferol, cetirizine
Alfamet Disease Interaction
Major: liver disease
Moderate: cerebrovascular disease, dialysis, hemolytic anemia, leukopenia, peripheral edema, pheochromocytoma
Minor: psychoses
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Volume of Distribution
The apparent volume of distribution ranges between 0.19 and 0.32L/kg and the total volume of distribution ranges from 0.41 to 0.72L/kg. Since methyldopa is lipid-soluble , it crosses the placental barrier, appears in cord blood, and appears in breast milk.
Elimination Route
Alfamet is incompletely absorbed from the gastrointestinal tract following oral administration. In healthy individuals, the inactive D-isomer is less readily absorbed than the active L-isomer. The mean bioavailability of methyldopa is 25%, ranging from eight to 62%. Following oral administration, about 50% of the dose is absorbed and Tmax is about three to six hours.
Half Life
The plasma half-life of methyldopa is 105 minutes. Following intravenous injection, the plasma half-life of methyldopa ranges from 90 to 127 minutes.
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Clearance
The renal clearance is about 130 mL/min in normal subjects and is decreased in patients with renal insufficiency.
Elimination Route
Approximately 70% of absorbed methyldopa is excreted in the urine as unchanged parent drug (24%) and α-methyldopa mono-O-sulfate (64%), with variability.3-O-methyl-α-methyldopa accounted for about 4% of urinary excretion products. Other metabolites like 3,4-dihydroxyphenylacetone, α-methyldopamine, and 3-O-methyl-α-methyldopamine are also excreted in urine.
Unabsorbed drug is excreted in feces as the unchanged parent compound. After oral doses, excretion is essentially complete in 36 hours.
Due to attenuated excretion in patients with renal failure, accumulation of the drug and its metabolites may occur, possibly leading to more profound and prolonged hypotensive effects in these patients.
Pregnancy & Breastfeeding use
Pregnancy Category B. Alfamet appears in breast milk. Therefore, caution should be exercised when Alfamet is given to a nursing woman.
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Contraindication
Alfamet is contraindicated in patients with:
- active hepatic disease, such as acute hepatitis and active cirrhosis.
- liver disorders previously associated with Alfamet therapy.
- hypersensitivity to any component of these products.
- On therapy with monoamine oxidase (MAO) inhibitors.
Special Warning
Pediatric Use: There are no well-controlled clinical trials in pediatric patients. Information on dosing in pediatric patients is supported by evidence from published literature regarding the treatment of hypertension in pediatric patients.
Acute Overdose
Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, lightheadedness, 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.
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Innovators Monograph
You find simplified version here Alfamet
| Dosage form |
Tab |
|---|---|
| Pack size |
30 |
| Potency |
250 Mg |
| Manufacturer |
I.E. Ulagay |
| Origin |
Turkey |
| Generic Name (Ingredient) |
Each Film Tablet Contains 250 Mg Methyldopa. |
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Patient Information leaflet
_1 _
_ _
KULLANMA TALİMATI
ALFAMET
® 250 MG FILM KAPLI TABLET
AĞIZDAN UYGULANIR.
_ETKIN MADDE_:
250 mg metildopa.
_YARDIMCI MADDELER_:
Sitrik
asit,
EDTA
disodyum,
PVP
K-30,
karboksimetil
selüloz, kolloidal silikon dioksit, magnezyum stearat, polivinil
alkol, titandioksit,
polietilen glikol/ macrogol, talk, quinoline yellow alüminyum lake,
yellow iron
oxide non-IRR
BU ILACI KULLANMAYA BAŞLAMADAN ÖNCE BU KULLANMA TALİMATINI
DIKKATLICE
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR.
_Bu _
_kullanma _
_talimatını _
_saklayınız. _
_Daha _
_sonra _
_tekrar _
_okumaya _
_ihtiyaç _
_duyabilirsiniz. _
_Eğer ilave sorularınız olursa, lütfen doktorunuza veya
eczacınıza danışınız. _
_Bu ilaç kişisel olarak sizin için reçete edilmiştir,
başkalarına vermeyiniz. _
_Bu ilacın kullanımı sırasında, doktora veya hastaneye
gittiğinizde doktorunuza _
_bu ilacı kullandığınızı söyleyiniz. _
_Bu talimatta yazılanlara aynen uyunuz. İlaç hakkında size
önerilen dozun dışında _
_YÜKSEK VEYA DÜŞÜK doz kullanmayınız._
BU KULLANMA TALIMATINDA:
_1._
_ _
_ALFAMET NEDIR VE NE IÇIN KULLANILIR? _
_2._
_ _
_ALFAMET’I KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER _
_3._
_ _
_ALFAMET NASIL KULLANILIR? _
_4._
_ _
_OLASI YAN ETKILER NELERDIR? _
_5._
_ _
_ALFAMET’IN SAKLANMASI _
BAŞLIKLARI YER ALMAKTADIR.
1. ALFAMET_ _NEDIR VE NE IÇIN KULLANILIR?
ALFAMET sarı, yuvarlak, kokusuz, bikonveks film tablet şeklinde bir
üründür. Metildopa
isimli etkin maddeyi içermektedir. Bu madde tansiyonu (kan
basıncını) düşürmeye yarayan
antihipertansifler denilen bir ilaç grubuna aittir.
ALFAMET yüksek tansiyon (hipertansiyon) tedavisinde
kullanılmaktadır.
_2 _
_ _
2. ALFAMET KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER
ALFAMET’I AŞAĞIDAKI DURUMLARDA KULLANMAYINIZ
Akut hepatit ve aktif siroz gibi aktif bir karaciğer hastalığınız
var ise,
Daha önceden metildopa tedavisine bağlı olarak karaciğer
rahatsızlığı geçirdiyseniz,
AL
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Summary of Product characteristics
_1 _
_ _
KISA ÜRÜN BİLGİSİ
1. BEŞERİ TIBBİ ÜRÜNÜN ADI
ALFAMET
®
250 mg film kaplı tablet
2. KALİTATİF VE KANTİTATİF BİLEŞİM
ETKIN MADDE:
Her bir film kaplı tablet 250 mg metildopa içerir.
YARDIMCI MADDELER:
Yardımcı maddeler için 6.1’e bakınız.
3. FARMASÖTİK FORM
Film kaplı tablet
Sarı, yuvarlak, kokusuz, bikonveks film kaplı tablet.
4. KLİNİK ÖZELLİKLER
4.1. TERAPÖTIK ENDIKASYONLAR
ALFAMET hipertansiyon tedavisinde endikedir.
4.2. POZOLOJI VE UYGULAMA ŞEKLI
POZOLOJI/UYGULAMA SIKLIĞI VE SÜRESI:
Yetişkinlerde:
Başlangıç dozu:
Metildopanın mutat başlangıç dozu ilk 48 saat içinde günde 2
veya 3 defa 250 mg'dır. Yeterli
bir yanıt alınana kadar, günlük doz tercihen iki günden az
olmayan aralıklarla azaltılabilir veya
artırılabilir. Sedasyonu mümkün olduğu kadar azaltmak için, doz
artırımlarına akşamları
başlanmalıdır. Doz düzenlemesiyle sabah hipotansiyonu, öğleden
sonra kan basıncı kontrolü
yapılmaksızın önlenebilir.
Diğer antihipertansif ilaçları alan hastalara bunların yerine
metildopa verileceği zaman, düzgün
bir
geçiş
sağlamak
için
bu
ilaçların
dozunda
ayarlama
yapılmasına
gerek
duyulabilir.
Metildopa, tiazidlerin dışında diğer antihipertansif ilaçlarla
verileceği zaman, metildopanın
başlangıç dozu bölünmüş dozlar halinde günlük en fazla 500 mg
olmalıdır; metildopa tiazidlere
ek olarak verileceği zaman tiazid dozunu değiştirmek
gerekmemektedir.
İdame dozu:
Metildopanın mutat günlük dozu 2-4 defa 500 mg ila 2 g'dır. Bazen
hastalar daha yüksek
dozlara yanıt verirlerse de, günlük önerilen maksimum doz 3
g'dır. Bir kez etkili doz aralığına
ulaşıldığında, 12 ila 24 saat içinde pek çok hastada uygun bir
kan basıncı yanıtı görülür.
_2 _
_ _
Metildopa, nispeten kısa etki süreli olduğundan dolayı ilacın
kesilmesinden genellikle 48 saat
sonra hipertansiyona dönüş meydana gelir. Bu durum kan
basıncının aşırı artışıyla komplike
değildir.
Genellikle tedavinin 2.
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Name of the medicinal product
The information provided in Name of the medicinal product of Alfamet
is based on data of another medicine with exactly the same composition as the Alfamet.
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Alfamet
Qualitative and quantitative composition
The information provided in Qualitative and quantitative composition of Alfamet
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Methyldopa
Therapeutic indications
The information provided in Therapeutic indications of Alfamet
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In the treatment of hypertension.
Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of Alfamet
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Posology
Use in adults:
Initial dosage: Usually 250 mg 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. The maximum recommended daily dosage is 3 g.
Many patients experience sedation for two or three days when therapy with ‘Alfamet’ is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first.
Withdrawal of ‘Alfamet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.
Patients with renal impairment:
Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses.
Other antihypertensives:
Therapy with ‘Alfamet’ may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually, as required. Following such previous antihypertensive therapy, ‘Alfamet’ should be limited to an initial dose of not more than 500 mg daily and increased as required at intervals of not less than two days.
When methyldopa is given to patients on other antihypertensives the dose of these agents may need to be adjusted to effect a smooth transition.
When 500 mg of ‘Alfamet’ is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily.
Paediatric population:
Initial dosage is based on 10 mg/kg of bodyweight daily in 2-4 oral doses. The daily dosage is then increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3.0 g daily, whichever is less.
Older people:
The initial dose in elderly patients should be kept as low as possible, not exceeding 250 mg daily; an appropriate starting dose in the elderly would be 125 mg b.d. increasing slowly as required, but not to exceed a maximum daily dosage of 2 g. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.
Method of administration
Oral.
Contraindications
The information provided in Contraindications of Alfamet
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— depression
— on therapy with monoamine oxidase inhibitors (MAOIs)
— with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma
— with porphyria.
Special warnings and precautions for use
The information provided in Special warnings and precautions for use of Alfamet
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Acquired haemolytic anaemia has occurred rarely; should symptoms suggest anaemia, haemoglobin and/or haematocrit determinations should be made. If anaemia is confirmed, tests should be done for haemolysis. If haemolytic anaemia is present, ‘Alfamet’ should be discontinued. Stopping therapy, with or without giving a corticosteroid, has usually brought prompt remission. Rarely, however, deaths have occurred.
Some patients on continued therapy with methyldopa develop a positive Coombs test. From the reports of different investigators, the incidence averages between 10% and 20%. A positive Coombs test rarely develops in the first six months of therapy, and if it has not developed within 12 months, it is unlikely to do so later on continuing therapy. Development is also dose-related, the lowest incidence occurring in patients receiving 1 g or less of methyldopa per day. The test becomes negative usually within weeks or months of stopping methyldopa.
Prior knowledge of a positive Coombs reaction will aid in evaluating a cross-match for transfusion. If a patient with a positive Coombs reaction shows an incompatible minor cross-match, an indirect Coombs test should be performed. If this is negative, transfusion with blood compatible in the major cross-match may be carried out. If positive, the advisability of transfusion should be determined by a haematologist.
Reversible leukopenia, with primary effect on granulocytes has been reported rarely. The granulocyte count returned to normal on discontinuing therapy. Reversible thrombocytopenia has occurred rarely.
Occasionally, fever has occurred within the first three weeks of therapy, sometimes associated with eosinophilia or abnormalities in liver-function tests. Jaundice, with or without fever, may also occur. Its onset is usually within the first two or three months of therapy. In some patients the findings are consistent with those of cholestasis. Rare cases of fatal hepatic necrosis have been reported. Liver biopsy, performed in several patients with liver dysfunction, showed a microscopic focal necrosis compatible with drug hypersensitivity. Liver-function tests and a total and differential white blood-cell count are advisable before therapy and at intervals during the first six weeks to twelve weeks of therapy, or whenever an unexplained fever occurs.
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.
Patients may require reduced doses of anaesthetics when on methyldopa. If hypotension does occur during anaesthesia, it can usually be controlled by vasopressors. The adrenergic receptors remain sensitive during treatment with methyldopa.
Dialysis removes methyldopa; therefore, hypertension may recur after this procedure.
Rarely, involuntary choreoathetotic movements have been observed during therapy with methyldopa in patients with severe bilateral cerebrovascular disease. Should these movements occur, therapy should be discontinued.
Interference with laboratory tests:
Methyldopa may interfere with the measurement of urinary uric acid by the phosphotungstate method, serum creatinine by the alkaline picrate method, and AST (SGOT) by colorimetric method. Interference with spectrophotometric methods for AST (SGOT) analysis has not been reported.
As methyldopa fluoresces at the same wavelengths as catecholamines, spuriously high amounts of urinary catecholamines may be reported interfering with a diagnosis of catecholamine-secreting tumours such as phaeochromocytoma or paraganglioma.
It is important to recognise this phenomenon before a patient with a possible phaeochromocytoma is subjected to surgery. Methyldopa does not interfere with measurements of VMA (vanillylmandelic acid) by those methods which convert VMA to vanillin. Methyldopa is contraindicated for the treatment of patients with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma.
Rarely, when urine is exposed to air after voiding, it may darken because of breakdown of methyldopa or its metabolites.
Effects on ability to drive and use machines
The information provided in Effects on ability to drive and use machines of Alfamet
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‘Alfamet’ may cause sedation, usually transient, during the initial period of therapy or whenever the dose is increased. If affected, patients should not carry out activities where alertness is necessary, such as driving a car or operating machinery.
Undesirable effects
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Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. If affected, patients should not attempt to drive, or operate machinery. Headache, asthenia or weakness may be noted as early and transient symptoms.
The following convention has been utilised for the classification of frequency: Very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (> 1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
|
System Organ Class |
Adverse event term |
Frequency |
|
Infections and infestations |
Sialoadenitis |
Not known |
|
Blood and lymphatic system disorders |
Haemolytic anaemia, bone-marrow failure, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia |
Not known |
|
Endocrine disorders |
Hyperprolactinaemia |
Not known |
|
Psychiatric disorders |
Psychic disturbances including nightmares, reversible mild psychoses or depression, decreased libido |
Not known |
|
Nervous system disorders |
Sedation (usually transient), headache, paraesthesia, Parkinsonism, VIIth nerve paralysis, choreoathetosis, mental impairment, carotid sinus syndrome, dizziness, symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure) |
Not known |
|
Cardiac disorders |
Bradycardia, angina pectoris, myocarditis, pericarditis, atrioventricular block |
Not known |
|
Vascular disorders |
Orthostatic hypotension (decrease daily dosage) |
Not known |
|
Respiratory, thoracic and mediastinal disorders |
Nasal congestion |
Not known |
|
Gastrointestinal disorders |
Nausea, vomiting, abdominal distension, constipation, flatulence, diarrhoea, colitis, dry mouth, glossodynia, tongue discolouration, pancreatitis |
Not known |
|
Hepatobiliary disorders |
Liver disorders including hepatitis, jaundice |
Not known |
|
Skin and subcutaneous tissue disorders |
Rash (eczema, lichenoid eruption), toxic epidermal necrolysis, angioedema, urticaria |
Not known |
|
Musculoskeletal and connective tissue disorders |
Lupus-like syndrome, mild arthralgia with or without joint swelling, myalgia |
Not known |
|
Reproductive system and breast disorders |
Breast enlargement, gynaecomastia, amenorrhoea, lactation disorder, erectile dysfunction, ejaculation failure |
Not known |
|
General disorder and administration site conditions |
Asthenia, oedema (and weigh gain) usually relieved by use of a diuretic. (Discontinue methyldopa if oedema progresses or signs of heart failure appear). Pyrexia |
Not known |
|
Investigations |
Positive Coombs test, positive tests for antinuclear antibody, LE cells, and rheumatoid factor, abnormal liver-function tests, increased blood urea |
Not known |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via; the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
Overdose
The information provided in Overdose of Alfamet
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Symptoms
Acute overdosage may produce acute hypotension with other responses attributable to brain and gastro-intestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distension, flatus, diarrhoea, nausea, and vomiting).
Management
If ingestion is recent, emesis may be induced or gastric lavage performed. There is no specific antidote. Methyldopa is dialysable. Treatment is symptomatic. Infusions may be helpful to promote urinary excretion. Special attention should be directed towards cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.
Administration of sympathomimetic agents may be indicated. When chronic overdosage is suspected, ‘Alfamet’ should be discontinued.
Pharmacodynamic properties
The information provided in Pharmacodynamic properties of Alfamet
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Pharmacotherapeutic group: antiadrenergic agents; ATC code C02AB
Mechanism of action
It appears that several mechanisms of action account for the clinically useful effects of methyldopa and the current generally accepted view is that its principal action is on the central nervous system. The antihypertensive effect of methyldopa is probably due to its metabolism to alpha-methylnoradrenaline, which 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, epinephrine (adrenaline) and norepinephrine (noradrenaline).
Pharmacokinetic properties
The information provided in Pharmacokinetic properties of Alfamet
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Absorption
Absorption of oral methyldopa is variable and incomplete.
Distribution
Bioavailability after oral administration averages 25%.
Biotransformation
Peak concentrations in plasma occur at two to three hours, and elimination of the drug is biphasic regardless of the route of administration. Plasma half-life is 1.8 ± 0.2 hours.
Elimination
Renal excretion accounts for about two thirds of drug clearance from plasma.
Pharmacotherapeutic group
The information provided in Pharmacotherapeutic group of Alfamet
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antiadrenergic agents; ATC code C02AB
Preclinical safety data
The information provided in Preclinical safety data of Alfamet
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No relevant information.
Incompatibilities
The information provided in Incompatibilities of Alfamet
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None known.
Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of Alfamet
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None.
Alfamet price
We have no data on the cost of the drug.
However, we will provide data for each active ingredient
The approximate cost of Methyldopa 250 mg per unit in online pharmacies is from 0.33$ to 0.64$, per package is from 28$ to 98$.
The approximate cost of Methyldopa 125 mg per unit in online pharmacies is from 0.3$ to 0.54$, per package is from 30$ to 142$.
The approximate cost of Methyldopa 500 mg per unit in online pharmacies is from 0.45$ to 0.91$, per package is from 35$ to 139$.