Product Elements:
Hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange colored 25 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange coloured 50 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange cloured 100 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 mannitol magnesium stearate orange cloured circular biconvex 10
Indications and Usage:
Indications and usage: essential hypertension, alone or as an adjunct.
Warnings:
Warnings: in a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. in such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. long-term treatment with steroids may be necessary. (see precautions , laboratory tests .)
Dosage and Administration:
Dosage and administration initiate therapy in gradually increasing dosages; adjust according to individual response. start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. for the second and subsequent weeks, increase dosage to 50 mg four times daily. for maintenance, adjust dosage to the lowest effective levels. the incidence of toxic reactions, particularly the l.e. cell syndrome, is high in the group of patients receiving large doses of hydralazine hydrochloride tablets, usp. in a few resistant patients, up to 300 mg of hydralazine hydrochloride tablets, usp daily may be required for a significant antihypertensive effect. in such cases, a lower dosage of hydralazine hydrochloride tablets, usp combined with a thiazide and/or reserpine or a beta blocker may be considered. however, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.
Contraindications:
Contraindications: hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
Adverse Reactions:
Adverse reactions adverse reactions with hydralazine are usually reversible when dosage is reduced. however, in some cases it may be necessary to discontinue the drug. the following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. common headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. less frequent digestive constipation, paralytic ileus. cardiovascular hypotension, paradoxical pressor response, edema. respiratory dyspnea. neurologic peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. genitourinary difficulty in urination. hematologic blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. hypersensitive reactions rash, urticaria, pruri
Read more...tus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. other nasal congestion, flushing, lacrimation, conjunctivitis. call your doctor for medical advice about side effects. you may report side effects to strides pharma inc. at 1-877-244-9825 or go to www.strides.com
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. teratogenic effects observed were cleft palate and malformations of facial and cranial bones. there are no adequate and well-controlled studies in pregnant women. although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydralazine in pediatric patients. the usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.
Overdosage:
Overdosage acute toxicity no deaths due to acute poisoning have been reported. highest known dose survived: adults, 10 g orally. oral ld 50 in rats: 173 and 187 mg/kg. signs and symptoms signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. treatment there is no specific antidote. the gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. an activated charcoal slurry may be instilled if conditions permit. these manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock. support of the cardiovascular system is of primary importance. shock should be treated with plasma expanders. if possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. tachycardia responds to beta blockers. digitalization may be necessary, and renal function should be monitored and supported as required. no experience has been reported with extracorporeal or peritoneal dialysis.
Description:
Description: hydralazine hydrochloride tablets, usp, is an antihypertensive, for oral administration. its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: c 8 h 8 n 4 ⢠hcl hydralazine hydrochloride, usp is a white to off-white, odorless crystalline powder. it is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. it melts at about 275°c, with decomposition, and has a molecular weight of 196.64. each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, usp. 25 mg, 50 mg or 100 mg tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and sunset yellow lake and 10 mg tablets contain magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, and sunset yellow lake. structure
Clinical Pharmacology:
Clinical pharmacology: although the precise mechanism of action of hydralazine is not fully understood, the major effects are on the cardiovascular system. hydralazine apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. hydralazine, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. the peripheral vasodilating effect of hydralazine results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. the preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. hydralazine usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal j
Read more...uxtaglomerular cells in response to reflex sympathetic discharge. this increase in renin activity leads to the production of angiotensin ii, which then causes stimulation of aldosterone and consequent sodium reabsorption. hydralazine also maintains or increases renal and cerebral blood flow. hydralazine is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. plasma levels of apparent hydralazine decline with a half-life of 3 to 7 hours. binding to human plasma protein is 87%. plasma levels of hydralazine vary widely among individuals. hydralazine is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydralazine and require lower doses to maintain control of blood pressure. hydralazine undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.
How Supplied:
How supplied hydralazine hydrochloride tablets, usp are supplied as: 10 mg 100 tablets in a hdpe bottle ndc: 64380-733-06 orange colored, circular, biconvex tablets, debossed "10" on one side and plain on other side. 500 tablets in a hdpe bottle ndc: 64380-733-07 1000 tablets in a hdpe bottle ndc: 64380-733-08 100 tablets in a hdpe bottle ndc: 64380-734-06 25 mg 500 tablets in a hdpe bottle ndc: 64380-734-07 orange colored circular, flat bevel edged tablets debossed "25" on one side & plain on other side 1000 tablets in a hdpe bottle ndc: 64380-734-08 100 tablets in a hdpe bottle ndc: 64380-735-06 50 mg 500 tablets in a hdpe bottle ndc: 64380-735-07 orange colored circular, flat bevel edged tablets debossed "50" on one side & plain on other side 1000 tablets in a hdpe bottle ndc: 64380-735-08 100 tablets in a hdpe bottle ndc: 64380-736-06 100 mg 500 tablets in a hdpe bottle ndc: 64380-736-07 orange colored circular, flat bevel edged tablets debossed "100" on one side & plain on other s
Read more...ide 1000 tablets in a hdpe bottle ndc: 64380-736-08 dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. keep this and all medications out of the reach of children manufactured by: strides pharma science ltd. bengaluru - 562106, india distributed by: strides pharma inc. east brunswick, nj 08816 revised: 07/2019
Information for Patients:
Information for patients patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.
Package Label Principal Display Panel:
Package label.principal display panel front panel strides pharma inc rx only ndc 64380-733-06 hydralazine hydrochloride tablets, usp 10 mg 100 tablets front panel strides pharma inc rx only ndc 64380-733-08 hydralazine hydrochloride tablets, usp 10 mg 1000 tablets front panel strides pharma inc rx only ndc 64380-734-06 hydralazine hydrochloride tablets, usp 25 mg 100 tablets 25mg-100scount-container-label front panel strides pharma inc rx only ndc 64380-735-06 hydralazine hydrochloride tablets, usp 50 mg 100 tablets 50mg-100scount-container-label front panel strides pharma inc rx only ndc 64380-736-06 hydralazine hydrochloride tablets, usp 100 mg 100 tablets 100mg-100s-count-container-label front panel strides pharma inc rx only ndc 64380-734-08 hydralazine hydrochloride tablets, usp 25 mg 1000 tablets 25mg-1000s-count-container-label front panel strides pharma inc rx only ndc 64380-735-08 hydralazine hydrochloride tablets, usp 50 mg 1000 tablets 50mg-1000s-count-container-label 10mg-10s 10 mg-1000s 25mg-100scount-container-label 50mg-100scount-container-label 100mg-100s-count-container-label 25mg-1000s-count-container-label 50mg-1000s-count-container-label