HydrALAZINE Hydrochloride

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Overview

What is HydrALAZINE Hydrochloride?

HydrALAZINE hydrochloride, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:

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. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.

What does HydrALAZINE Hydrochloride look like?

What are the available doses of HydrALAZINE Hydrochloride?

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What should I talk to my health care provider before I take HydrALAZINE Hydrochloride?

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How should I use HydrALAZINE Hydrochloride?

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What interacts with HydrALAZINE Hydrochloride?

Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

What are the warnings of HydrALAZINE Hydrochloride?

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

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 )

What are the precautions of HydrALAZINE Hydrochloride?

General

Myocardial stimulation produced by hydrALAZINE can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

The “hyperdynamic” circulation caused by hydrALAZINE may accentuate specific cardiovascular inadequacies. For example, hydrALAZINE may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from hydrALAZINE but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.

In hypertensive patients with normal kidneys who are treated with hydrALAZINE, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of hydrALAZINE. However, as with any antihypertensive agent, hydrALAZINE should be used with caution in patients with advanced renal damage.

Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop.

Information for Patients

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests

Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydrALAZINE even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydrALAZINE.

Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.

Drug/Drug Interactions

MAO inhibitors should be used with caution in patients receiving hydrALAZINE.

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.

Administration of hydrALAZINE with food results in higher plasma levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydrALAZINE continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydrALAZINE by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. HydrALAZINE was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatocyte DNA repair studies. Additional and studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydrALAZINE.

The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydrALAZINE use, epidemiologic studies have so far been insufficient to arrive at any conclusions.

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 to15 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.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hydrALAZINE is administered to a nursing woman.

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.

What are the side effects of HydrALAZINE Hydrochloride?

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. Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. constipation, paralytic ileus. hypotension, paradoxical pressor response, edema. dyspnea. peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. difficulty in urination. blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. nasal congestion, flushing, lacrimation, conjunctivitis.

What should I look out for while using HydrALAZINE Hydrochloride?

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What might happen if I take too much HydrALAZINE Hydrochloride?

How should I store and handle HydrALAZINE Hydrochloride?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only10 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-309-01) and 1000 (NDC 67787-309-10).25 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-310-01) and 1000 (NDC 67787-310-10).50 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-311-01) and 1000 (NDC 67787-311-10).100 mg - Orange, round, biconvex tablets debossed with on one side and on the other, supplied in bottles of 100 (NDC 67787-312-01) and 500 (NDC 67787-312-05). Dispense in a tight, light-resistant container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured by:InvaGen Pharmaceuticals, IncHauppauge, NY 11788Rev: 10/08Rx only

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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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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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