Pauco Hydralazine Hydrochloride Injection USP

PAUCO HYDRALAZINE HYDROCHLORIDE INJECTION USP

 

COMPOSITION

Each ml contains:
Hydralazine Hydrochloride USP 20mg
Water for injection USP q.s.

 

CATEGORY

Antihypertensives

 

GENERAL INFORMATION

Hydralazine is antihypertensive agent it acts as a vasodilator. It relaxes and expands blood vessels and lowers the blood pressure. It also function as antioxidant. It has been available for many years, though it was initially thought not to be particularly effective because tachyphylaxis to hypertensive effects developed rapidly. Now the benefits of combination therapy are recognized, and may be used more effectively particularly in severe hypertension.

 

PHARMACOKINETICS

After oral administration its absorption is almost complete and rapid. It is subject to significant first pass metabolism in liver.

On Set of Action: 10-20 minutes.

Duration of Action: 3-6 hours.

 

INDICATIONS

Hypertension (moderate or severe), hypertension with renal involvement.

 

DOSAGE & ADMINISTRATION

Hypertension

Adults: Initially, 10mg P.O. q.i.d. After 2 to 4 days, may increase to 25mg P.O. q.i.d. for remainder of first week; may then increase further to 50 mg P.O. q.i.d., up to 300 mg/day. Once maintenance dosage is established, may give in two daily doses.

Children: Initially 0.75 mg/kg/day P.O. in four divided doses; may increase gradually over 3 to 4 weeks to 7.5 mg/kg or 200 mg/day.

Neonates: 0.5mg/kg P.O., I.M., or I.V. q 4 to 8 hours.

Heart failure

Adults: Initially, 50 to 75 mg P.O. q.i.d.; may increase up to 600 mg/day given in three to four divided doses.

Eclampsia

Adults: 5 mg I.V., followed by another 5mg I.V. q 15 to 20 minutes until blood pressure decreases adequately. If no response occurs after a total dose of 20mg, prescriber may consider alternative.

 

CONTRAINDICATIONS

Coronary heart disease, dissecting aortic aneurysm, idiopathic constrictive pericarditis, valvular stenosis (aortic or mitral).

 

ADVERSE EFFECTS

Nausea, vomiting, tachycardia, dizziness, fatigue, weakness, palpitations, headache, postural hypotension, constipation, anxiety, nasal congestion, lupus like syndrome, sleep disturbances.

 

WARNINGS/PRECAUTIONS

Use cautiously in:

– Suspected CV or cerebrovascular diseases, severe renal or hepatic disease.

– Pregnant on breast feeding patients.

– Children.

 

INTERACTIONS

MAOIs, Thiazide diuretics & TCAs: Antihypertensive effect of hydralazine enhanced.

Sympathomimetics: Use these agents with great caution since hydralazine alone may cause tachycardia and angina.

Propranolol, Metoprolol: Oral bioavailability of these agents may be increased. Also they countered reflex tachycardia.

Parenteral antihypertensive drugs: (e.g. Diazoxide): Profound hypotensive episodes may occur.

Alcohol: Hydralazine potentiates effect of alcohol.

 

STORAGE

Store between temperature 8 to 25oC. Do not freeze. Protect from light.

Keep out of the reach of children.

 

PRESENTATION

10 ampoules of 1mI are enclosed in a plastic tray and each tray packed in a printed box.

 

Manufactured by

KWALITY PHARMACEUTICALS (P) LTD.

Nag Kalan, Majitha Road, Amritsar – India.

 

Distributed by

PAUCO PHARMACEUTICALS

INDUSTRIES LTD.

Anambra State, Nigeria.