Apresoline

Before taking Apresoline, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• if you are allergic to Apresoline, aspirin, tartrazine (a yellow dye in some processed foods and medications), or any other drugs.
• prescription and nonprescription medications you are taking, especially indomethacin (Indocin), metoprolol (Lopressor), propranolol (Inderal), and vitamins.
• if you have or have ever had coronary artery disease, rheumatic heart disease, kidney or liver disease, or a heart attack.
• if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Apresoline, call your doctor.
• if you are having surgery, including dental surgery
• if you drink alcohol. Alcohol can make the side effects from Apresoline worse.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take Apresoline exactly as prescribed.

Apresoline comes in tablet and capsule form and is taken usually four times a day with food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Apresoline at the same time.

This medication is also available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional when there is urgent need. Apresoline injection should be used only when the drug cannot be given orally.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, dizziness, fast heart rate, warmth or tingling under your skin, chest pain, or fainting.

In the U.S.

• Apresoline

Available Dosage Forms:

• Tablet

Therapeutic Class: Peripheral Vasodilator

Hydralazine is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in a mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can decrease the risk of heart attacks and strokes.

Hydralazine works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

Apresoline, hydralazine hydrochloride USP, is an antihypertensive, available as 10-, 25-, 50-, and 100-mg tablets 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.

     Inactive Ingredients. Acacia, D&C Yellow No. 10 (10-mg tablets), FD&C Blue No. 1 (25-mg and 50-mg tablets), FD&C Yellow No. 5 and FD&C Yellow No. 6 (100-mg tablets), lactose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, starch, and stearic acid.

Adverse reactions with Apresoline 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

Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2-4 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 Apresoline.

      In a few resistant patients, up to 300 mg of Apresoline daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of Apresoline 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.

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Hydralazine is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

Hydralazine is used to treat high blood pressure (hypertension).

Hydralazine may also be used for other purposes not listed in this medication guide.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Use should be avoided during the first two trimesters of pregnancy; use is not recommended during the third trimester unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C

Animal studies have revealed evidence of teratogenicity, including cleft palate and malformed facial and cranial bones at higher doses. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.