Rx Item-Ramipril 2.5MG 100 Cap by Aurobindo Pharma USA Gen Altace

Clinical Information
Gen. Code and Des.
15940 ramipril ORAL CAPSULE 2.5 MG
GCN and Des.
48542 ramipril ORAL CAPSULE 2.5 MG
Strength
2.5MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24320400 ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
24084404 ANGIOTENSIN-CONVERT.ENZYME INHIB(HYPOTN)
Active Ingredients
3585 ramipril 87333195
Inactive Ingredients
10141 red dye
10143 yellow dye
2549 gelatin 9000708





RAMIPRIL- ramipril capsule
Atlantic Biologicals Corps

WARNING: USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue ramipril as soon as possible (5.6).

1 INDICATIONS AND USAGE

1.1 Hypertension


Ramipril Capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension
The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with ramipril alone, a diuretic can be added.

2.4 General Dosing Information
Generally, swallow ramipril capsules whole. The ramipril capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of applesauce or mixed in 4 oz. (120 mL) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, the mixture should be consumed in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.
DOSAGE FORMS AND STRENGTHS

Ramipril Capsules USP are supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg and 10 mg of ramipril.
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Ramipril and ramiprilat inhibit ACE in human subjects and animals. Angiotensin converting enzyme is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In hypertensive patients with normal renal function treated with ramipril alone for up to 56 weeks, approximately 4% of patients during the trial had an abnormally high serum potassium and an increase from baseline greater than 0.75 mEq/L, and none of the patients had an abnormally low potassium and a decrease from baseline greater than 0.75 mEq/L. In the same study, approximately 2% of patients treated with ramipril and hydrochlorothiazide for up to 56 weeks had abnormally high potassium values and an increase from baseline of 0.75 mEq/L or greater; and approximately 2% had abnormally low values and decreases from baseline of 0.75 mEq/L or greater [see 5 WARNINGS AND PRECAUTIONS (5.8)]. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.

The effect of ramipril on hypertension appears to result at least in part from inhibition of both tissue and circulating ACE activity, thereby reducing angiotensin II formation in tissue and plasma.

Angiotensin converting enzyme is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of ramipril remains to be elucidated.

While the mechanism through which ramipril lowers blood pressure is believed to be primarily suppression of the renin�angiotensin�aldosterone system, ramipril has an antihypertensive effect even in patients with low�renin hypertension. Although ramipril was antihypertensive in all races studied, Black hypertensive patients (usually a low�renin hypertensive population) had a blood pressure lowering response to monotherapy, albeit a smaller average response, than non�Black patients.

Rx Item-Ramipril 2.5MG 100 Cap by Aurobi
Item No. RX327991, 327991, NDC No.: 65862-0475-01, 65862-475-01, 6586247501, 65862047501, 0475-01, 047501 UPC No. 3-65862-47501-5, 365862-475015, 365862475015

Rx Item-Ramipril 2.5MG 100 Cap by Aurobi
Item No. RX327991, 327991, NDC No.: 65862-0475-01, 65862-475-01, 6586247501, 65862047501, 0475-01, 047501 UPC No. 3-65862-47501-5, 365862-475015, 365862475015

Rx Item-Ramipril 2.5MG 100 Cap by Aurobi
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Aurobindo Pharma USA
Item No. RX327991, 327991, NDC No.: 65862-0475-01, 65862-475-01, 6586247501, 65862047501, 0475-01, 047501 UPC No. 3-65862-47501-5, 365862-475015, 365862475015

Rx Item-Ramipril 2.5MG 100 Cap
Item No. RX327991, 327991, NDC No.: 65862-0475-01, 65862-475-01, 6586247501, 65862047501, 0475-01, 047501 UPC No. 3-65862-47501-5, 365862-475015, 365862475015