Hydralazine hydrochloride.
Orange round, convex with film coated tablet. One side has letter "H" and another side has figure 25.
Each film-coated tablet contains Hydralazine hydrochloride 25 mg.
Pharmacology: Pharmacodynamics: Mechanism of action: Hydralazine reduces peripheral resistance and blood pressure as a result of direct vasodilatory effect on vascular smooth muscle; the effect on arterioles is greater than on veins.
Pharmacokinetics: Absorption: Rapidly absorbed after oral administration.
Metabolism: Hepatically acetylate; extensive first-pass effect (oral).
Excretion: Urine (as metabolite).
Time to peak: 1-2 hours.
Half-life elimination: 3-7 hours.
Protein-binding: 87%.
Bioavailability: Increase with food.
Management of moderate to severe hypertension as an adjunct to other antihypertensive agents such as diuretics and β-blockers, when this has not obtained a satisfactory effect.
Adult: Initial dosage: 25 mg 2 times daily for the first 2-4 days; increase to 25 mg 4 times daily for balance of the first week.
Dosage titration: 50 mg 4 times daily from the second week on.
Maintenance dosage: Adjust dosage to the lowest effective levels. Up to 300 mg/day may be required in resistant patients.
Mode of Administration: Administered without regard to meals. However, food enhances bioavailability; administer consistently with regard to meals.
Overdose and Treatment: Overdosage of hydralazine may produce hypotension, tachycardia, headache and generalized skin flushing. Myocardial ischemia and cardiac arrhythmia may develop; profound shock can occur in severe overdosage.
There is no specific antidote for the treatment of hydralazine overdosage. Support of the cardiovascular system is most important for the treatment of hydralazine overdosage. Evacuation of gastric contents using adequate precautions to protect the airway and prevent aspiration should be done only after cardiovascular status has been stabilized.
Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
Hydralazine is contraindicated in patients with severe tachycardia, dissecting aortic aneurysm, heart failure with high cardiac output, cor pulmonale, or myocardial insufficiency due to mechanical obstruction, for example aortic or mitral stenosis or constrictive.
Hydralazine is also contraindicated in patients with idiopathic systemic lupus erythematosus (SLE) and related disorders.
May cause a drug-induced lupus-like syndrome including glomerulonephritis, especially in patients receiving higher doses.
Postural hypotension may occur.
Use with caution in patients with cerebral vascular accidents and suspected coronary artery disease (CAD); myocardial stimulation produced by hydralazine can cause angina attacks and electrocardiogram (ECG) changes of myocardial ischemia; has been implicated in the production of myocardial infarction.
Use with caution in patients with mitral valvular disease; may increased pulmonary artery pressure in these patients.
Use with caution in patients with advanced renal impairment; dosage adjustment.
Hydralazine has been associated with peripheral neuritis (eg, paresthesia, numbness, tingling), possibly due to an antipyridoxine effect. Pyridoxine therapy should be initiated with onset of such symptoms.
Blood dyscrasias (eg, reduction in haemoglobin and red blood cell count, leucopenia, agranulocytosis, purpura) may occur, discontinue therapy if these hematologic effects occur.
Pregnancy: Safety use of hydralazine in pregnancy has not been established. Hydralazine should not be used during pregnancy unless the possible benefits outweigh the potential risks to the fetus.
Lactation: It is not known whether hydralazine is distributed into breast milk. Because many drugs are distributed into milk, the drug should be used with caution in nursing women.
Common: Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris.
Less frequent: Cardiovascular: Hypotension, paradoxical pressor response, edema.
Central nervous system: Peripheral neuritis, evidenced by paresthesia, numbness and tingling, dizziness, tremors, muscle cramps, psychotic reactions characterized by depression, disorientation or anxiety.
Hydralazine may increase the levels/effects of Amifostine, Antipsychotic agents (second generation), Bromperidol, Duloxetine, Hypotension associated agents, Levodopa, Nitroprusside, Pholcodine.
The levels/effects of Hydralazine may be increased by Afuzosine, Barbiturates, Benperidol, Brigatinib, Brimonidine (Topical), Dapoxetine, Diazoxide, Herbs (Hypotensive properties), Lormetazepam, Molsidomine, Naftofpidil, Nicergoline, Nicorandil, Obinutuzumab, Pentoxifylline, Phosphodiesterase 5 inhibitors, Prostacyclin analogues, Quinegolide.
The levels/effects of Hydralazine may be decreased by Amphetamines, Brigatinib, Bromperidol, Herbs (Hypertensive properties), Methylphenidate, Nonsteroidal anti-inflammatory agents, Yohimbine.
C02DB02 - hydralazine ; Belongs to the class of hydrazinophthalazine derivatives. Used in the treatment of hypertension.
Apreszine 25 FC tab 25 mg
50 × 10's
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